Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Sponsor
Seagen Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02855359
Collaborator
(none)
24
35
4
21.4
0.7
0
Study Details
Study Description
Brief Summary
This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
Study Design
Study Type:
Interventional
Actual Enrollment
:
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b
Study Start Date
:
Aug 1, 2016
Actual Primary Completion Date
:
Jan 1, 2018
Actual Study Completion Date
:
May 15, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: denintuzumab mafodotin + RCHOP Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
Drug: denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
| Experimental: denintuzumab mafodotin + RCHP Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) |
Drug: denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
| Experimental: denintuzumab mafodotin + RCHOP or RCHP Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP |
Drug: denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
| Active Comparator: RCHOP Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Outcome Measures
Primary Outcome Measures
- Part B Outcome Measure: Complete Response Rate (CR) [N/A - Endpoint not assessed]
Study did not progress to Part B.
- Part A and Part B Outcome Measure: Incidence of Adverse Events [54.7 weeks]
Part A data only; study did not progress to Part B.
- Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities [Up to 183 days]
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Secondary Outcome Measures
- Event-free Survival (EFS) Between Study Arms in Part B [N/A - Endpoint not assessed]
Study did not progress to Part B
- Progression-free Survival (PFS) Between Study Arms in Part B [N/A - Endpoint not assessed]
Study did not progress to Part B.
- Overall Survival (OS) Between Study Arms in Part B [N/A - Endpoint not assessed]
Study did not progress to Part B.
- Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B [N/A - Endpoint not assessed]
Study did not progress to Part B.
- Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B [N/A - Endpoint not assessed]
Study did not progress to Part B.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
-
patients must have high intermediate or high risk disease
-
Tumor tissue available from most recent biopsy to determine cell of origin
-
Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
-
Eastern Cooperative Oncology Group performance status ≤2
-
Age 18 years or older
-
Adequate study baseline laboratory parameters
Exclusion Criteria:
-
Previous history of treated indolent lymphoma
-
History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
-
History of progressive multifocal leukoencephalopathy
-
Cerebral/meningeal disease related to the underlying malignancy
-
Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Saint Bernards Cancer Center | Jonesboro | Arkansas | United States | 72401 |
| 3 | City of Hope | Duarte | California | United States | 91010 |
| 4 | Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | United States | 92708 |
| 5 | Pacific Hematology Oncology Associates | San Francisco | California | United States | 94115 |
| 6 | University of Colorado Health Memorial Hospital | Colorado Springs | Colorado | United States | 80909 |
| 7 | Poudre Valley Hospital Harmony Campus | Fort Collins | Colorado | United States | 80528 |
| 8 | Central Georgia Cancer Care | Macon | Georgia | United States | 31201 |
| 9 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 10 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 11 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
| 12 | Montgomery Cancer Center | Mount Sterling | Kentucky | United States | 40353 |
| 13 | Tulane University Hospital and Clinic | New Orleans | Louisiana | United States | 70122 |
| 14 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 15 | Virginia Piper Cancer Institute | Minneapolis | Minnesota | United States | 55407 |
| 16 | Hattiesburg Clinic (Forrest General Hospital) | Hattiesburg | Mississippi | United States | 39401 |
| 17 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
| 18 | San Juan Oncology Associates | Farmington | New Mexico | United States | 87401 |
| 19 | Montefiore Medical Center - Bronx | Bronx | New York | United States | 10467 |
| 20 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 21 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 22 | Regional Medical Oncology Center | Wilson | North Carolina | United States | 27893 |
| 23 | Gabrail Cancer Center Research | Canton | Ohio | United States | 44718 |
| 24 | University Hospitals Seidman Cancer Center | Cleveland | Ohio | United States | 44106 |
| 25 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 26 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 27 | Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
| 28 | Tennessee Oncology / Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 29 | Baylor Health - Baylor University Medical Center | Dallas | Texas | United States | 75246 |
| 30 | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | United States | 79410 |
| 31 | Scott and White Memorial Hospital - Temple | Temple | Texas | United States | 76508 |
| 32 | Kadlec Clinic Hematology and Oncology | Kennewick | Washington | United States | 99336 |
| 33 | Vista Oncology INC PS | Olympia | Washington | United States | 98502 |
| 34 | Northwest Medical Specialties, PLLC | Tacoma | Washington | United States | 98405 |
| 35 | Ponce Medical School Foundation | Ponce | Puerto Rico | 00716 |
Sponsors and Collaborators
- Seagen Inc.
Investigators
- Study Director: Juan Pinelli, PA-C, MMSc., Seagen Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT02855359
Other Study ID Numbers:
- SGN19A-004
First Posted:
Aug 4, 2016
Last Update Posted:
Mar 11, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Seagen Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Period Title: Overall Study | ||||
| STARTED | 11 | 13 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 11 | 13 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Total |
|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Total of all reporting groups |
| Overall Participants | 11 | 13 | 24 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
67
|
72
|
69
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
45.5%
|
4
30.8%
|
9
37.5%
|
| Male |
6
54.5%
|
9
69.2%
|
15
62.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
11
100%
|
13
100%
|
24
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
7.7%
|
1
4.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
10
90.9%
|
12
92.3%
|
22
91.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
9.1%
|
0
0%
|
1
4.2%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | |||
| 0: Normal activity |
2
18.2%
|
3
23.1%
|
5
20.8%
|
| 1: Symptoms, but ambulatory |
8
72.7%
|
5
38.5%
|
13
54.2%
|
| 2: In bed less than 50% of the time |
1
9.1%
|
5
38.5%
|
6
25%
|
Outcome Measures
| Title | Part B Outcome Measure: Complete Response Rate (CR) |
|---|---|
| Description | Study did not progress to Part B. |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Part A and Part B Outcome Measure: Incidence of Adverse Events |
|---|---|
| Description | Part A data only; study did not progress to Part B. |
| Time Frame | 54.7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP |
|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 11 | 13 |
| Any Treatment-emergent adverse event (TEAE) |
11
100%
|
13
100%
|
| Any Grade 3-5 TEAE |
11
100%
|
12
92.3%
|
| Any Treatment-related Adverse Event (AE) |
10
90.9%
|
13
100%
|
| Any DM treatment-related AE |
9
81.8%
|
13
100%
|
| Any RCHOP/RCHP treatment-related AE |
10
90.9%
|
13
100%
|
| Any AE with Outcome of Death |
2
18.2%
|
1
7.7%
|
| Any Serious Adverse Event (SAE) |
5
45.5%
|
4
30.8%
|
| Any Treatment-Related SAE |
4
36.4%
|
3
23.1%
|
| Any DM Treatment-Related SAE |
2
18.2%
|
2
15.4%
|
| Title | Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities |
|---|---|
| Description | Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. |
| Time Frame | Up to 183 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP |
|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 11 | 13 |
| Alanine aminotransferase increased |
3
27.3%
|
4
30.8%
|
| Hypoalbuminemia |
3
27.3%
|
4
30.8%
|
| Alkaline phosphatase increased |
5
45.5%
|
8
61.5%
|
| Aspartate aminotransferase increased |
5
45.5%
|
9
69.2%
|
| Blood bilirubin increased |
0
0%
|
4
30.8%
|
| Hypercalcemia |
3
27.3%
|
0
0%
|
| Hypocalcemia |
5
45.5%
|
5
38.5%
|
| Hyperglycemia |
8
72.7%
|
11
84.6%
|
| Hypoglycemia |
1
9.1%
|
4
30.8%
|
| Hypermagnesemia |
0
0%
|
4
30.8%
|
| Hypomagnesemia |
4
36.4%
|
4
30.8%
|
| Hypophosphatemia |
5
45.5%
|
5
38.5%
|
| Hypokalemia |
6
54.5%
|
7
53.8%
|
| Hypernatremia |
1
9.1%
|
1
7.7%
|
| Hyponatremia |
4
36.4%
|
12
92.3%
|
| Hyperuricemia |
0
0%
|
1
7.7%
|
| Anemia |
10
90.9%
|
12
92.3%
|
| Leukopenia |
10
90.9%
|
13
100%
|
| Lymphopenia |
9
81.8%
|
13
100%
|
| Neutropenia |
9
81.8%
|
11
84.6%
|
| Thrombocytopenia |
10
90.9%
|
13
100%
|
| Title | Event-free Survival (EFS) Between Study Arms in Part B |
|---|---|
| Description | Study did not progress to Part B |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Progression-free Survival (PFS) Between Study Arms in Part B |
|---|---|
| Description | Study did not progress to Part B. |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Overall Survival (OS) Between Study Arms in Part B |
|---|---|
| Description | Study did not progress to Part B. |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B |
|---|---|
| Description | Study did not progress to Part B. |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B |
|---|---|
| Description | Study did not progress to Part B. |
| Time Frame | N/A - Endpoint not assessed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint not assessed; study did not progress to Part B. |
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | Denintuzumab Mafodotin + RCHOP or RCHP | RCHOP |
|---|---|---|---|---|
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| Measure Participants | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | 54.7 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | ||
| Arm/Group Description | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | ||
All Cause Mortality |
||||
| Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/11 (18.2%) | 2/13 (15.4%) | ||
Serious Adverse Events |
||||
| Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/11 (45.5%) | 4/13 (30.8%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 2/11 (18.2%) | 3/13 (23.1%) | ||
| Neutropenia | 0/11 (0%) | 1/13 (7.7%) | ||
| Thrombocytopenia | 0/11 (0%) | 1/13 (7.7%) | ||
| Cardiac disorders | ||||
| Coronary artery disease | 0/11 (0%) | 1/13 (7.7%) | ||
| Palpitations | 1/11 (9.1%) | 0/13 (0%) | ||
| General disorders | ||||
| Asthenia | 1/11 (9.1%) | 0/13 (0%) | ||
| Fatigue | 0/11 (0%) | 1/13 (7.7%) | ||
| Pyrexia | 0/11 (0%) | 1/13 (7.7%) | ||
| Infections and infestations | ||||
| Pneumocystis jirovecii pneumonia | 0/11 (0%) | 1/13 (7.7%) | ||
| Pneumonia bacterial | 1/11 (9.1%) | 0/13 (0%) | ||
| Septic shock | 0/11 (0%) | 1/13 (7.7%) | ||
| Staphylococcal bacteraemia | 0/11 (0%) | 1/13 (7.7%) | ||
| Metabolism and nutrition disorders | ||||
| Tumour lysis syndrome | 1/11 (9.1%) | 0/13 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/11 (0%) | 1/13 (7.7%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/11 (9.1%) | 0/13 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/11 (9.1%) | 0/13 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonia aspiration | 1/11 (9.1%) | 0/13 (0%) | ||
| Pulmonary embolism | 0/11 (0%) | 1/13 (7.7%) | ||
| Respiratory failure | 0/11 (0%) | 1/13 (7.7%) | ||
| Vascular disorders | ||||
| Hypotension | 1/11 (9.1%) | 1/13 (7.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Denintuzumab Mafodotin + RCHP | Denintuzumab Mafodotin + RCHOP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | 13/13 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 6/11 (54.5%) | 8/13 (61.5%) | ||
| Anaemia | 6/11 (54.5%) | 6/13 (46.2%) | ||
| Thrombocytopenia | 2/11 (18.2%) | 6/13 (46.2%) | ||
| Leukopenia | 2/11 (18.2%) | 1/13 (7.7%) | ||
| Immune thrombocytopenic purpura | 0/11 (0%) | 2/13 (15.4%) | ||
| Leukocytosis | 0/11 (0%) | 1/13 (7.7%) | ||
| Lymphopenia | 1/11 (9.1%) | 0/13 (0%) | ||
| Pancytopenia | 0/11 (0%) | 1/13 (7.7%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 0/11 (0%) | 1/13 (7.7%) | ||
| Atrial fibrillation | 1/11 (9.1%) | 0/13 (0%) | ||
| Cardiac failure congestive | 0/11 (0%) | 1/13 (7.7%) | ||
| Myocardial ischaemia | 0/11 (0%) | 1/13 (7.7%) | ||
| Palpitations | 1/11 (9.1%) | 0/13 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Corneal dystrophy | 1/11 (9.1%) | 0/13 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear discomfort | 0/11 (0%) | 1/13 (7.7%) | ||
| Vertigo | 1/11 (9.1%) | 0/13 (0%) | ||
| Eye disorders | ||||
| Vision blurred | 7/11 (63.6%) | 10/13 (76.9%) | ||
| Keratopathy | 5/11 (45.5%) | 6/13 (46.2%) | ||
| Dry eye | 3/11 (27.3%) | 7/13 (53.8%) | ||
| Keratitis | 1/11 (9.1%) | 5/13 (38.5%) | ||
| Visual acuity reduced | 1/11 (9.1%) | 4/13 (30.8%) | ||
| Lacrimation increased | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Eye pain | 2/11 (18.2%) | 1/13 (7.7%) | ||
| Eye pruritus | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Photophobia | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Eye irritation | 0/11 (0%) | 2/13 (15.4%) | ||
| Ocular toxicity | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Asthenopia | 0/11 (0%) | 1/13 (7.7%) | ||
| Cataract | 1/11 (9.1%) | 0/13 (0%) | ||
| Conjunctivitis allergic | 1/11 (9.1%) | 0/13 (0%) | ||
| Corneal epithelium defect | 0/11 (0%) | 1/13 (7.7%) | ||
| Corneal oedema | 1/11 (9.1%) | 0/13 (0%) | ||
| Corneal opacity | 1/11 (9.1%) | 0/13 (0%) | ||
| Diplopia | 0/11 (0%) | 1/13 (7.7%) | ||
| Eye oedema | 0/11 (0%) | 1/13 (7.7%) | ||
| Glaucoma | 1/11 (9.1%) | 0/13 (0%) | ||
| Macular degeneration | 0/11 (0%) | 1/13 (7.7%) | ||
| Ulcerative keratitis | 0/11 (0%) | 1/13 (7.7%) | ||
| Vitreous floaters | 1/11 (9.1%) | 0/13 (0%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 5/11 (45.5%) | 6/13 (46.2%) | ||
| Constipation | 2/11 (18.2%) | 7/13 (53.8%) | ||
| Diarrhoea | 3/11 (27.3%) | 4/13 (30.8%) | ||
| Vomiting | 3/11 (27.3%) | 3/13 (23.1%) | ||
| Stomatitis | 2/11 (18.2%) | 3/13 (23.1%) | ||
| Abdominal pain upper | 2/11 (18.2%) | 0/13 (0%) | ||
| Dry mouth | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Oral disorder | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Abdominal discomfort | 1/11 (9.1%) | 0/13 (0%) | ||
| Eructation | 0/11 (0%) | 1/13 (7.7%) | ||
| Gastrooesophageal reflux disease | 0/11 (0%) | 1/13 (7.7%) | ||
| Glossodynia | 1/11 (9.1%) | 0/13 (0%) | ||
| Haemorrhoidal haemorrhage | 1/11 (9.1%) | 0/13 (0%) | ||
| General disorders | ||||
| Fatigue | 7/11 (63.6%) | 6/13 (46.2%) | ||
| Pyrexia | 3/11 (27.3%) | 4/13 (30.8%) | ||
| Asthenia | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Mucosal inflammation | 2/11 (18.2%) | 2/13 (15.4%) | ||
| Oedema peripheral | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Chills | 2/11 (18.2%) | 1/13 (7.7%) | ||
| Chest discomfort | 0/11 (0%) | 2/13 (15.4%) | ||
| Generalised oedema | 0/11 (0%) | 1/13 (7.7%) | ||
| Non-cardiac chest pain | 1/11 (9.1%) | 0/13 (0%) | ||
| Pain | 1/11 (9.1%) | 0/13 (0%) | ||
| Infections and infestations | ||||
| Fungal infection | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Oral candidiasis | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Pneumonia | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Bronchitis | 1/11 (9.1%) | 0/13 (0%) | ||
| Candida infection | 0/11 (0%) | 1/13 (7.7%) | ||
| Conjunctivitis | 0/11 (0%) | 1/13 (7.7%) | ||
| Eye infection fungal | 0/11 (0%) | 1/13 (7.7%) | ||
| Fungal skin infection | 1/11 (9.1%) | 0/13 (0%) | ||
| Oral herpes | 0/11 (0%) | 1/13 (7.7%) | ||
| Pharyngitis | 1/11 (9.1%) | 0/13 (0%) | ||
| Sepsis | 1/11 (9.1%) | 0/13 (0%) | ||
| Skin infection | 0/11 (0%) | 1/13 (7.7%) | ||
| Urinary tract infection | 0/11 (0%) | 1/13 (7.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Infusion related reaction | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Fall | 0/11 (0%) | 2/13 (15.4%) | ||
| Tooth fracture | 1/11 (9.1%) | 0/13 (0%) | ||
| Investigations | ||||
| Neutrophil count decreased | 1/11 (9.1%) | 2/13 (15.4%) | ||
| White blood cell count decreased | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Blood alkaline phosphatase increased | 0/11 (0%) | 2/13 (15.4%) | ||
| Platelet count decreased | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Troponin increased | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Blood creatinine increased | 1/11 (9.1%) | 0/13 (0%) | ||
| Brain natriuretic peptide increased | 0/11 (0%) | 1/13 (7.7%) | ||
| Electrocardiogram QT prolonged | 1/11 (9.1%) | 0/13 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/11 (18.2%) | 5/13 (38.5%) | ||
| Dehydration | 2/11 (18.2%) | 2/13 (15.4%) | ||
| Hypokalaemia | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Hyperglycaemia | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Hypocalcaemia | 2/11 (18.2%) | 0/13 (0%) | ||
| Acidosis | 1/11 (9.1%) | 0/13 (0%) | ||
| Hypercalcaemia | 1/11 (9.1%) | 0/13 (0%) | ||
| Hyperkalaemia | 1/11 (9.1%) | 0/13 (0%) | ||
| Hyperphosphataemia | 1/11 (9.1%) | 0/13 (0%) | ||
| Iron deficiency | 0/11 (0%) | 1/13 (7.7%) | ||
| Tumour lysis syndrome | 1/11 (9.1%) | 0/13 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 0/11 (0%) | 3/13 (23.1%) | ||
| Pain in extremity | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Back pain | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Bone pain | 0/11 (0%) | 2/13 (15.4%) | ||
| Joint swelling | 0/11 (0%) | 2/13 (15.4%) | ||
| Myalgia | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Musculoskeletal pain | 0/11 (0%) | 1/13 (7.7%) | ||
| Neck pain | 1/11 (9.1%) | 0/13 (0%) | ||
| Pain in jaw | 1/11 (9.1%) | 0/13 (0%) | ||
| Nervous system disorders | ||||
| Headache | 4/11 (36.4%) | 1/13 (7.7%) | ||
| Dizziness | 2/11 (18.2%) | 2/13 (15.4%) | ||
| Neuropathy peripheral | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Dysgeusia | 1/11 (9.1%) | 2/13 (15.4%) | ||
| Paraesthesia | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Peripheral sensory neuropathy | 0/11 (0%) | 2/13 (15.4%) | ||
| Balance disorder | 0/11 (0%) | 1/13 (7.7%) | ||
| Lethargy | 1/11 (9.1%) | 0/13 (0%) | ||
| Peroneal nerve palsy | 0/11 (0%) | 1/13 (7.7%) | ||
| Psychiatric disorders | ||||
| Insomnia | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Adjustment disorder with depressed mood | 0/11 (0%) | 1/13 (7.7%) | ||
| Anxiety | 0/11 (0%) | 1/13 (7.7%) | ||
| Renal and urinary disorders | ||||
| Pollakiuria | 1/11 (9.1%) | 4/13 (30.8%) | ||
| Nocturia | 0/11 (0%) | 2/13 (15.4%) | ||
| Urinary incontinence | 1/11 (9.1%) | 0/13 (0%) | ||
| Reproductive system and breast disorders | ||||
| Vulvovaginal pruritus | 0/11 (0%) | 1/13 (7.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/11 (9.1%) | 4/13 (30.8%) | ||
| Cough | 1/11 (9.1%) | 3/13 (23.1%) | ||
| Dyspnoea exertional | 2/11 (18.2%) | 0/13 (0%) | ||
| Hypoxia | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Epistaxis | 1/11 (9.1%) | 0/13 (0%) | ||
| Nasal congestion | 0/11 (0%) | 1/13 (7.7%) | ||
| Oropharyngeal pain | 0/11 (0%) | 1/13 (7.7%) | ||
| Pleural effusion | 0/11 (0%) | 1/13 (7.7%) | ||
| Pneumonitis | 0/11 (0%) | 1/13 (7.7%) | ||
| Pulmonary oedema | 0/11 (0%) | 1/13 (7.7%) | ||
| Sinus congestion | 0/11 (0%) | 1/13 (7.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 3/11 (27.3%) | 3/13 (23.1%) | ||
| Erythema | 0/11 (0%) | 2/13 (15.4%) | ||
| Night sweats | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Photosensitivity reaction | 0/11 (0%) | 2/13 (15.4%) | ||
| Rash | 1/11 (9.1%) | 1/13 (7.7%) | ||
| Dermatitis acneiform | 0/11 (0%) | 1/13 (7.7%) | ||
| Ecchymosis | 0/11 (0%) | 1/13 (7.7%) | ||
| Nail discolouration | 0/11 (0%) | 1/13 (7.7%) | ||
| Rash maculo-papular | 1/11 (9.1%) | 0/13 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 2/11 (18.2%) | 4/13 (30.8%) | ||
| Hypertension | 0/11 (0%) | 2/13 (15.4%) | ||
| Pallor | 1/11 (9.1%) | 0/13 (0%) | ||
Limitations/Caveats
Study was ended by sponsor prior to Part B enrollment.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Seattle Genetics, Inc. |
| Phone | 855-473-2436 |
| medinfo@seagen.com |
Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT02855359
Other Study ID Numbers:
- SGN19A-004
First Posted:
Aug 4, 2016
Last Update Posted:
Mar 11, 2019
Last Verified:
Feb 1, 2019