Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To determine the response rate in patients with previously untreated CD20-positive bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower- or high-dose of ofatumumab.
Secondary
-
To determine the progression-free survival (PFS) of patients treated with these regimens.
-
To determine the toxicity profile of these regimens in these patients.
-
To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic doublet trials.
-
To evaluate the two ofatumumab doses by independent comparison of response, PFS, and toxicity to a historical control in previously untreated patients with follicular NHL.
-
To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk patients and compare to low- and intermediate-risk stratified patients by standard FLIPI scoring to determine a more reliable indicator of response and PFS.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
-
Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
-
Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and bone marrow sample collection for correlative studies.
After completion of study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 8 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9. |
Biological: ofatumumab
Given IV
|
Experimental: Arm II Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9. |
Biological: ofatumumab
Given IV
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (Complete or Partial Response) by Month 12 [From baseline to month 12]
The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.
Secondary Outcome Measures
- Median Progression-free Survival Time [From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years]
The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria:
-
Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease
-
Stage III or IV disease
-
WHO grade 1, 2, or 3a disease
-
Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies
-
No fine-needle aspirates for diagnosis
-
Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC
-
At least 1 site of measurable disease that is > 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies
-
Non-measurable disease alone not allowed, including the following:
-
Bone lesions (lesions if present should be noted)
-
Ascites
-
Pleural/pericardial effusion
-
Lymphangitis cutis/pulmonis
-
Bone marrow (involvement by NHL should be noted)
-
Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI)
-
FLIPI score meeting 1 or 2 of the following risk factors:
-
Age > 60 years
-
Involvement of > 4 nodal sites
-
Stage III-IV disease
-
Hemoglobin < 12.0 g/dL
-
LDH normal
-
Risk determined by the following:
-
Low Risk: 0-1 of the above risk factors
-
Intermediate Risk: 2 risk factors
-
Poor Risk: ≥ 3 risk factors
-
No known CNS involvement
PATIENT CHARACTERISTICS:
-
ECOG performance status 0-2
-
ANC ≥ 1,000/μL
-
Platelet count ≥ 75,000/μL
-
Creatinine clearance ≥ 30 mL/min
-
Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL)
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
-
Patients with HIV infection allowed provided the following criteria are met:
-
No evidence of coinfection with hepatitis B or C
-
CD4+ cell count ≥ 400/mm³
-
No evidence of resistant strains of HIV
-
HIV viral load < 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load < 50 copies if on anti-HIV therapy
-
No history of AIDS-defining conditions
-
No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)
-
HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing
-
After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required)
PRIOR CONCURRENT THERAPY:
-
No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL
-
Prior involved-field radiation therapy allowed
-
More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease
-
No concurrent dexamethasone or other steroids as antiemetics
-
No live virus vaccination within 6 weeks prior to study entry
-
No concurrent zidvoudine or stavudine
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
2 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
3 | Cleveland Clinic Florida - Weston | Weston | Florida | United States | 33331 |
4 | Illinois CancerCare - Bloomington | Bloomington | Illinois | United States | 61701 |
5 | Illinois CancerCare - Canton | Canton | Illinois | United States | 61520 |
6 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
7 | Illinois CancerCare - Eureka | Eureka | Illinois | United States | 61530 |
8 | Galesburg Clinic, PC | Galesburg | Illinois | United States | 61401 |
9 | Illinois CancerCare - Macomb | Macomb | Illinois | United States | 61455 |
10 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
11 | Community Cancer Center | Normal | Illinois | United States | 61761 |
12 | Illinois CancerCare - Community Cancer Center | Normal | Illinois | United States | 61761 |
13 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
14 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
15 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
16 | Illinois CancerCare - Pekin | Pekin | Illinois | United States | 61603 |
17 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
18 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
19 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
20 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
21 | Illinois CancerCare - Peru | Peru | Illinois | United States | 61354 |
22 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
23 | Illinois CancerCare - Spring Valley | Spring Valley | Illinois | United States | 61362 |
24 | Iowa Blood and Cancer Care | Cedar Rapids | Iowa | United States | 52402 |
25 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
26 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
27 | Mecosta County Medical Center | Big Rapids | Michigan | United States | 49307 |
28 | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
29 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
30 | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
31 | Mercy General Health Partners | Muskegon | Michigan | United States | 49444 |
32 | Spectrum Health Reed City Hospital | Reed City | Michigan | United States | 49677 |
33 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
34 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
35 | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | United States | 03301 |
36 | New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | United States | 03106 |
37 | Lakes Region General Hospital | Laconia | New Hampshire | United States | 03246 |
38 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
39 | Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | United States | 11042 |
40 | Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | United States | 11030 |
41 | Mount Kisco Medical Group, PC | Mount Kisco | New York | United States | 10549-3417 |
42 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
43 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
44 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
45 | Kinston Medical Specialists | Kinston | North Carolina | United States | 28501 |
46 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
47 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
48 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Cara A. Rosenbaum, MD, University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-50901
- CALGB-50901
- GSK-CALGB-50901
- CDR0000683083
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) |
---|---|---|
Arm/Group Description | Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). |
Period Title: Overall Study | ||
STARTED | 15 | 36 |
COMPLETED | 15 | 32 |
NOT COMPLETED | 0 | 4 |
Baseline Characteristics
Arm/Group Title | Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) | Total |
---|---|---|---|
Arm/Group Description | Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Total of all reporting groups |
Overall Participants | 15 | 36 | 51 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
63
|
58
|
60
|
Sex: Female, Male (Count of Participants) | |||
Female |
4
26.7%
|
19
52.8%
|
23
45.1%
|
Male |
11
73.3%
|
17
47.2%
|
28
54.9%
|
Region of Enrollment (Count of Participants) | |||
United States |
15
100%
|
36
100%
|
51
100%
|
Outcome Measures
Title | Overall Response Rate (Complete or Partial Response) by Month 12 |
---|---|
Description | The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR. |
Time Frame | From baseline to month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Patients who completed the study and were not ineligible were included in this analysis. |
Arm/Group Title | Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) |
---|---|---|
Arm/Group Description | Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). |
Measure Participants | 15 | 32 |
Number (95% Confidence Interval) [percentage of patients] |
60
|
84
|
Title | Median Progression-free Survival Time |
---|---|
Description | The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis. |
Time Frame | From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years |
Outcome Measure Data
Analysis Population Description |
---|
Patients who completed the study and were not ineligible were included in this analysis. |
Arm/Group Title | Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) |
---|---|---|
Arm/Group Description | Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). |
Measure Participants | 15 | 32 |
Median (95% Confidence Interval) [years] |
1.9
|
1.9
|
Adverse Events
Time Frame | From baseline to month 12 | |||
---|---|---|---|---|
Adverse Event Reporting Description | Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table. | |||
Arm/Group Title | Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) | ||
Arm/Group Description | Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). | ||
All Cause Mortality |
||||
Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/36 (0%) | ||
Serious Adverse Events |
||||
Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/15 (13.3%) | 8/36 (22.2%) | ||
Cardiac disorders | ||||
Acute coronary syndrome | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Gastrointestinal disorders | ||||
Small intestinal obstruction | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
General disorders | ||||
Fatigue | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Infusion related reaction | 0/15 (0%) | 0 | 3/36 (8.3%) | 3 |
Infections and infestations | ||||
Bone infection | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Infections and infestations - Other, specify | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Investigations | ||||
Lymphocyte count decreased | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 2 |
White blood cell decreased | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Pneumonitis | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Arm I (Low-dose Ofatumumab) | Arm II (High-dose Ofatumumab) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 15/15 (100%) | 35/36 (97.2%) | ||
Blood and lymphatic system disorders | ||||
Anemia | 2/15 (13.3%) | 5 | 6/36 (16.7%) | 23 |
Leukocytosis | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Lymph node pain | 1/15 (6.7%) | 1 | 1/36 (2.8%) | 1 |
Cardiac disorders | ||||
Aortic valve disease | 1/15 (6.7%) | 4 | 0/36 (0%) | 0 |
Cardiac disorders - Other, specify | 0/15 (0%) | 0 | 1/36 (2.8%) | 4 |
Palpitations | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Sinus bradycardia | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Ear and labyrinth disorders | ||||
Ear pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Hearing impaired | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Tinnitus | 1/15 (6.7%) | 2 | 0/36 (0%) | 0 |
Vertigo | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Eye disorders | ||||
Blurred vision | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Eye disorders - Other, specify | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Gastrointestinal disorders | ||||
Abdominal pain | 1/15 (6.7%) | 1 | 7/36 (19.4%) | 20 |
Bloating | 0/15 (0%) | 0 | 1/36 (2.8%) | 3 |
Constipation | 1/15 (6.7%) | 1 | 4/36 (11.1%) | 7 |
Dental caries | 0/15 (0%) | 0 | 2/36 (5.6%) | 8 |
Diarrhea | 2/15 (13.3%) | 2 | 7/36 (19.4%) | 18 |
Dyspepsia | 0/15 (0%) | 0 | 6/36 (16.7%) | 18 |
Flatulence | 1/15 (6.7%) | 4 | 0/36 (0%) | 0 |
Gastritis | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Gastroesophageal reflux disease | 1/15 (6.7%) | 1 | 4/36 (11.1%) | 7 |
Mucositis oral | 1/15 (6.7%) | 2 | 0/36 (0%) | 0 |
Nausea | 3/15 (20%) | 8 | 13/36 (36.1%) | 29 |
Rectal hemorrhage | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Vomiting | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
General disorders | ||||
Chills | 1/15 (6.7%) | 1 | 4/36 (11.1%) | 11 |
Edema limbs | 1/15 (6.7%) | 2 | 3/36 (8.3%) | 10 |
Edema trunk | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Fatigue | 11/15 (73.3%) | 32 | 23/36 (63.9%) | 75 |
Fever | 1/15 (6.7%) | 1 | 4/36 (11.1%) | 5 |
Flu like symptoms | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
General disorders and administration site conditions - Other, specify | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
Infusion related reaction | 13/15 (86.7%) | 19 | 29/36 (80.6%) | 33 |
Malaise | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Neck edema | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Non-cardiac chest pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Pain | 1/15 (6.7%) | 2 | 4/36 (11.1%) | 9 |
Immune system disorders | ||||
Allergic reaction | 1/15 (6.7%) | 3 | 1/36 (2.8%) | 2 |
Cytokine release syndrome | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 2 |
Infections and infestations | ||||
Bronchial infection | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 3 |
Infections and infestations - Other, specify | 2/15 (13.3%) | 2 | 2/36 (5.6%) | 2 |
Sinusitis | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Skin infection | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Upper respiratory infection | 0/15 (0%) | 0 | 4/36 (11.1%) | 4 |
Urinary tract infection | 1/15 (6.7%) | 1 | 4/36 (11.1%) | 4 |
Vaginal infection | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Injury, poisoning and procedural complications | ||||
Bruising | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
Fall | 2/15 (13.3%) | 2 | 0/36 (0%) | 0 |
Injury, poisoning and procedural complications - Other, specify | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Investigations | ||||
Alanine aminotransferase increased | 0/15 (0%) | 0 | 5/36 (13.9%) | 7 |
Alkaline phosphatase increased | 0/15 (0%) | 0 | 1/36 (2.8%) | 5 |
Aspartate aminotransferase increased | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 3 |
Blood bilirubin increased | 0/15 (0%) | 0 | 3/36 (8.3%) | 11 |
Creatinine increased | 1/15 (6.7%) | 2 | 3/36 (8.3%) | 5 |
Lymphocyte count decreased | 3/15 (20%) | 17 | 11/36 (30.6%) | 41 |
Neutrophil count decreased | 0/15 (0%) | 0 | 6/36 (16.7%) | 12 |
Platelet count decreased | 2/15 (13.3%) | 9 | 2/36 (5.6%) | 11 |
Weight gain | 1/15 (6.7%) | 2 | 3/36 (8.3%) | 7 |
Weight loss | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
White blood cell decreased | 2/15 (13.3%) | 5 | 10/36 (27.8%) | 26 |
Metabolism and nutrition disorders | ||||
Anorexia | 3/15 (20%) | 4 | 2/36 (5.6%) | 3 |
Dehydration | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
Hypercalcemia | 0/15 (0%) | 0 | 1/36 (2.8%) | 6 |
Hyperglycemia | 5/15 (33.3%) | 10 | 12/36 (33.3%) | 46 |
Hyperkalemia | 1/15 (6.7%) | 2 | 2/36 (5.6%) | 3 |
Hypernatremia | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Hyperuricemia | 0/15 (0%) | 0 | 3/36 (8.3%) | 9 |
Hypoalbuminemia | 3/15 (20%) | 7 | 3/36 (8.3%) | 5 |
Hypocalcemia | 2/15 (13.3%) | 2 | 3/36 (8.3%) | 3 |
Hypoglycemia | 1/15 (6.7%) | 4 | 1/36 (2.8%) | 1 |
Hypokalemia | 1/15 (6.7%) | 2 | 2/36 (5.6%) | 2 |
Hypomagnesemia | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Hyponatremia | 4/15 (26.7%) | 4 | 6/36 (16.7%) | 12 |
Hypophosphatemia | 2/15 (13.3%) | 3 | 5/36 (13.9%) | 6 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/15 (6.7%) | 1 | 6/36 (16.7%) | 16 |
Arthritis | 0/15 (0%) | 0 | 3/36 (8.3%) | 5 |
Back pain | 5/15 (33.3%) | 12 | 3/36 (8.3%) | 3 |
Bone pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Buttock pain | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Chest wall pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Generalized muscle weakness | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Musculoskeletal and connective tissue disorder - Other, specify | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Myalgia | 2/15 (13.3%) | 2 | 3/36 (8.3%) | 4 |
Neck pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Pain in extremity | 3/15 (20%) | 6 | 3/36 (8.3%) | 6 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Tumor pain | 1/15 (6.7%) | 5 | 1/36 (2.8%) | 1 |
Nervous system disorders | ||||
Brachial plexopathy | 0/15 (0%) | 0 | 1/36 (2.8%) | 2 |
Dizziness | 1/15 (6.7%) | 1 | 5/36 (13.9%) | 9 |
Dysarthria | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Dysgeusia | 1/15 (6.7%) | 4 | 0/36 (0%) | 0 |
Headache | 2/15 (13.3%) | 12 | 9/36 (25%) | 19 |
Memory impairment | 0/15 (0%) | 0 | 1/36 (2.8%) | 2 |
Peripheral sensory neuropathy | 1/15 (6.7%) | 2 | 3/36 (8.3%) | 9 |
Presyncope | 0/15 (0%) | 0 | 1/36 (2.8%) | 2 |
Sinus pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Syncope | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Psychiatric disorders | ||||
Anxiety | 1/15 (6.7%) | 7 | 5/36 (13.9%) | 16 |
Confusion | 1/15 (6.7%) | 2 | 1/36 (2.8%) | 1 |
Depression | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 11 |
Insomnia | 4/15 (26.7%) | 6 | 11/36 (30.6%) | 29 |
Restlessness | 0/15 (0%) | 0 | 2/36 (5.6%) | 3 |
Renal and urinary disorders | ||||
Chronic kidney disease | 0/15 (0%) | 0 | 2/36 (5.6%) | 8 |
Urinary frequency | 1/15 (6.7%) | 1 | 1/36 (2.8%) | 1 |
Urinary tract obstruction | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Reproductive system and breast disorders | ||||
Genital edema | 1/15 (6.7%) | 2 | 0/36 (0%) | 0 |
Pelvic pain | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Reproductive system and breast disorders - Other, specify | 1/15 (6.7%) | 2 | 0/36 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Allergic rhinitis | 2/15 (13.3%) | 2 | 3/36 (8.3%) | 6 |
Bronchospasm | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
Cough | 4/15 (26.7%) | 9 | 7/36 (19.4%) | 12 |
Dyspnea | 6/15 (40%) | 13 | 12/36 (33.3%) | 27 |
Epistaxis | 1/15 (6.7%) | 1 | 1/36 (2.8%) | 1 |
Hoarseness | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Laryngopharyngeal dysesthesia | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Nasal congestion | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 2 |
Postnasal drip | 1/15 (6.7%) | 1 | 3/36 (8.3%) | 3 |
Productive cough | 1/15 (6.7%) | 1 | 1/36 (2.8%) | 2 |
Respiratory, thoracic and mediastinal disorders - Other, specify | 3/15 (20%) | 6 | 0/36 (0%) | 0 |
Sore throat | 3/15 (20%) | 3 | 2/36 (5.6%) | 2 |
Skin and subcutaneous tissue disorders | ||||
Alopecia | 0/15 (0%) | 0 | 1/36 (2.8%) | 1 |
Dry skin | 0/15 (0%) | 0 | 5/36 (13.9%) | 11 |
Erythema multiforme | 0/15 (0%) | 0 | 2/36 (5.6%) | 2 |
Hyperhidrosis | 2/15 (13.3%) | 5 | 2/36 (5.6%) | 4 |
Pruritus | 2/15 (13.3%) | 3 | 7/36 (19.4%) | 12 |
Rash acneiform | 0/15 (0%) | 0 | 3/36 (8.3%) | 3 |
Rash maculo-papular | 1/15 (6.7%) | 1 | 2/36 (5.6%) | 2 |
Skin and subcutaneous tissue disorders - Other, specify | 1/15 (6.7%) | 1 | 0/36 (0%) | 0 |
Urticaria | 1/15 (6.7%) | 2 | 4/36 (11.1%) | 6 |
Vascular disorders | ||||
Flushing | 0/15 (0%) | 0 | 2/36 (5.6%) | 5 |
Hot flashes | 1/15 (6.7%) | 2 | 2/36 (5.6%) | 2 |
Hypertension | 3/15 (20%) | 13 | 11/36 (30.6%) | 45 |
Hypotension | 2/15 (13.3%) | 2 | 2/36 (5.6%) | 2 |
Lymphedema | 0/15 (0%) | 0 | 1/36 (2.8%) | 2 |
Vascular disorders - Other, specify | 0/15 (0%) | 0 | 1/36 (2.8%) | 7 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT 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 | Cara Rosenbaum, MD |
---|---|
Organization | Weill Cornell Medicine Cornell University |
Phone | (646) 962-6500 |
car9156@med.cornell.edu |
- CALGB-50901
- CALGB-50901
- GSK-CALGB-50901
- CDR0000683083