Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Sponsor
Massachusetts General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01282476
Collaborator
Dana-Farber Cancer Institute (Other), Beth Israel Deaconess Medical Center (Other)
18
3
1
38
6
0.2
Study Details
Study Description
Brief Summary
Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory studies. However, it is not known if it will show the same activity in humans. Panobinostat has been given to participants with various types of cancers, including DLBCL, in previous research studies. In this study panobinostat will be given with the the antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.
If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
Actual Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Panobinostat/Rituximab single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
Drug: Panobinostat with Rituximab
Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate [1 year]
Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). Overall response (OR) = Complete response (CR) + Partial response (PR)
Secondary Outcome Measures
- Progression-free Survival Rate [6 months]
Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
- Toxicities [1 year]
Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Relapsed or refractory DLBCL
-
More than 1 line of prior chemotherapy
Exclusion Criteria:
-
Currently receiving anticancer therapy or investigational agents
-
Major surgery within last 4 weeks
-
Known leptomeningeal or brain metastases
-
Known HIV infection
-
Uncontrolled fungal, bacterial, viral or other infection
-
History of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 3 years
-
Hepatitis B or C positive
-
GI disease
-
Pregnant or breastfeeding
-
Prior treatment with an HDAC inhibitor including valproic acid
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02214 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 3 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
Investigators
- Principal Investigator: Jeremy S Abramson, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Jeremy Abramson, MD,
Director, Lymphoma Program,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01282476
Other Study ID Numbers:
- 10-441
First Posted:
Jan 25, 2011
Last Update Posted:
May 9, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Jeremy Abramson, MD,
Director, Lymphoma Program,
Massachusetts General Hospital
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Panobinostat/Rituximab |
|---|---|
| Arm/Group Description | Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
| Period Title: Overall Study | |
| STARTED | 18 |
| COMPLETED | 7 |
| NOT COMPLETED | 11 |
Baseline Characteristics
| Arm/Group Title | Panobinostat/Rituximab |
|---|---|
| Arm/Group Description | Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
| Overall Participants | 18 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
68
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
38.9%
|
| Male |
11
61.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
5.6%
|
| Not Hispanic or Latino |
17
94.4%
|
| Unknown or Not Reported |
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White |
17
94.4%
|
| Other |
1
5.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
18
100%
|
| Histology (Count of Participants) | |
| Centroblastic DLBCL(Diffuse large B cell lymphoma) |
1
5.6%
|
| DLBCL follicular cell derivation w/high grade BCL |
1
5.6%
|
| DLBCL not otherwise specified |
14
77.8%
|
| DLBCL of follicular center derivation |
1
5.6%
|
| Gray zone lymphoma |
1
5.6%
|
| EKG (electrocardiogram) (Count of Participants) | |
| Abnormal |
3
16.7%
|
| Normal |
15
83.3%
|
| elevated LDH (Lactate dehydrogenase) (Count of Participants) | |
| Yes |
9
50%
|
| No |
3
16.7%
|
| Missing |
6
33.3%
|
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) (Count of Participants) | |
| 00-Fully Active |
7
38.9%
|
| 01-Restricted |
8
44.4%
|
| 02-Ambulatory and Capable of Self Care |
3
16.7%
|
| Disease status (Count of Participants) | |
| Refractory |
10
55.6%
|
| Relapsed |
8
44.4%
|
| Number of extranodal sites (Count of Participants) | |
| 0 |
1
5.6%
|
| 1 |
3
16.7%
|
| 2 |
3
16.7%
|
| 3 |
9
50%
|
| 6 |
2
11.1%
|
| Number of target lesions (Count of Participants) | |
| 0-2 |
4
22.2%
|
| 3-5 |
6
33.3%
|
| 6+ |
8
44.4%
|
| Number of non-target lesions (Count of Participants) | |
| 0-2 |
12
66.7%
|
| 3-5 |
4
22.2%
|
| 6+ |
2
11.1%
|
| Time from last prior therapy (days) [Median (Full Range) ] | |
| Median (Full Range) [days] |
117
|
| Number of prior therapies (Count of Participants) | |
| 1-4 |
7
38.9%
|
| 5-8 |
9
50%
|
| 9+ |
2
11.1%
|
| Number of prior non-surgical therapies (Count of Participants) | |
| 0-2 |
6
33.3%
|
| 3-5 |
7
38.9%
|
| 6-8 |
5
27.8%
|
| Number of prior surgeries (Count of Participants) | |
| 0 |
12
66.7%
|
| 1 |
2
11.1%
|
| 2 |
2
11.1%
|
| 3 |
1
5.6%
|
| 4 |
1
5.6%
|
| Number of prior radiation treatments (Count of Participants) | |
| 0 |
12
66.7%
|
| 1 |
3
16.7%
|
| 2 |
2
11.1%
|
| 3 |
1
5.6%
|
Outcome Measures
| Title | Overall Response Rate |
|---|---|
| Description | Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). Overall response (OR) = Complete response (CR) + Partial response (PR) |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Panobinostat/Rituximab |
|---|---|
| Arm/Group Description | Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
| Measure Participants | 18 |
| Number (90% Confidence Interval) [percentage of participants] |
11
61.1%
|
| Title | Progression-free Survival Rate |
|---|---|
| Description | Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Panobinostat/Rituximab |
|---|---|
| Arm/Group Description | Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
| Measure Participants | 18 |
| Number (90% Confidence Interval) [percentage of participants] |
6
33.3%
|
| Title | Toxicities |
|---|---|
| Description | Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Panobinostat/Rituximab |
|---|---|
| Arm/Group Description | Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. |
| Measure Participants | 18 |
| Grade 1 |
5
27.8%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
1
5.6%
|
| Grade 4 |
7
38.9%
|
| Did not have any |
4
22.2%
|
| Grade 1 |
7
38.9%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
3
16.7%
|
| Grade 4 |
0
0%
|
| Did not have any |
7
38.9%
|
| Grade 1 |
3
16.7%
|
| Grade 2 |
3
16.7%
|
| Grade 3 |
4
22.2%
|
| Grade 4 |
0
0%
|
| Did not have any |
8
44.4%
|
| Grade 1 |
5
27.8%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
2
11.1%
|
| Grade 4 |
0
0%
|
| Did not have any |
10
55.6%
|
| Grade 1 |
5
27.8%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
13
72.2%
|
| Grade 1 |
0
0%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
3
16.7%
|
| Grade 4 |
1
5.6%
|
| Did not have any |
13
72.2%
|
| Grade 1 |
4
22.2%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
13
72.2%
|
| Grade 1 |
2
11.1%
|
| Grade 2 |
2
11.1%
|
| Grade 3 |
0
0%
|
| Grade 4 |
1
5.6%
|
| Did not have any |
13
72.2%
|
| Grade 1 |
0
0%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
2
11.1%
|
| Grade 4 |
1
5.6%
|
| Did not have any |
14
77.8%
|
| Grade 1 |
4
22.2%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
14
77.8%
|
| Grade 1 |
4
22.2%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
14
77.8%
|
| Grade 1 |
3
16.7%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
15
83.3%
|
| Grade 1 |
3
16.7%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
15
83.3%
|
| Grade 1 |
3
16.7%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
15
83.3%
|
| Grade 1 |
0
0%
|
| Grade 2 |
0
0%
|
| Grade 3 |
2
11.1%
|
| Grade 4 |
1
5.6%
|
| Did not have any |
15
83.3%
|
| Grade 1 |
3
16.7%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
15
83.3%
|
| Grade 1 |
0
0%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
2
11.1%
|
| Did not have any |
16
88.9%
|
| Grade 1 |
2
11.1%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
16
88.9%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
0
0%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
0
0%
|
| Grade 2 |
0
0%
|
| Grade 3 |
1
5.6%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
0
0%
|
| Grade 2 |
1
5.6%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
1
5.6%
|
| Grade 2 |
0
0%
|
| Grade 3 |
0
0%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
| Grade 1 |
0
0%
|
| Grade 2 |
0
0%
|
| Grade 3 |
1
5.6%
|
| Grade 4 |
0
0%
|
| Did not have any |
17
94.4%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Panobinostat/Rituximab | |
| Arm/Group Description | single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. | |
All Cause Mortality |
||
| Panobinostat/Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Panobinostat/Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/18 (55.6%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 1/18 (5.6%) | 1 |
| Death from disease progression | 2/18 (11.1%) | 2 |
| Leukocytopenia | 1/18 (5.6%) | 1 |
| Neutropenia | 1/18 (5.6%) | 1 |
| Thrombocytopenia | 6/18 (33.3%) | 6 |
| Cardiac disorders | ||
| Hypotension | 1/18 (5.6%) | 1 |
| General disorders | ||
| Death | 3/18 (16.7%) | 3 |
| Headache | 1/18 (5.6%) | 1 |
| Pain (back) | 1/18 (5.6%) | 1 |
| Infections and infestations | ||
| Right lower extremity cellulitis | 1/18 (5.6%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypokalemia | 2/18 (11.1%) | 2 |
| Hypophosphatemia | 2/18 (11.1%) | 2 |
| Nervous system disorders | ||
| Syncope | 1/18 (5.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 1/18 (5.6%) | 1 |
| Shortness of Breath | 1/18 (5.6%) | 1 |
| Vascular disorders | ||
| Bilateral Deep Vein Thrombosis | 1/18 (5.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Panobinostat/Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | 18/18 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 12/18 (66.7%) | 29 |
| Cardiac disorders | ||
| Myocarditis | 1/18 (5.6%) | 1 |
| Gastrointestinal disorders | ||
| Diarrhea | 8/18 (44.4%) | 10 |
| Nausea | 6/18 (33.3%) | 7 |
| Abdominal pain | 6/18 (33.3%) | 6 |
| Constipation | 4/18 (22.2%) | 6 |
| Dry mouth | 1/18 (5.6%) | 2 |
| Dysphagia | 1/18 (5.6%) | 1 |
| Flatulence | 1/18 (5.6%) | 1 |
| Gastroesophageal reflux | 1/18 (5.6%) | 1 |
| Mucositis oral | 1/18 (5.6%) | 1 |
| Vomiting | 1/18 (5.6%) | 1 |
| General disorders | ||
| Fatigue | 13/18 (72.2%) | 24 |
| Edema limbs | 4/18 (22.2%) | 4 |
| Pain | 2/18 (11.1%) | 2 |
| Edema face | 1/18 (5.6%) | 1 |
| Fever | 1/18 (5.6%) | 1 |
| General disorders | 1/18 (5.6%) | 1 |
| Infusion related reaction | 1/18 (5.6%) | 1 |
| Non-cardiac chest pain | 1/18 (5.6%) | 1 |
| Hepatobiliary disorders | ||
| Hepatobiliary disorders | 1/18 (5.6%) | 1 |
| Infections and infestations | ||
| Urinary tract infection | 1/18 (5.6%) | 1 |
| Investigations | ||
| Platelet count decreased | 12/18 (66.7%) | 30 |
| Lymphocyte count decrease | 7/18 (38.9%) | 19 |
| Neutrophil count decrease | 4/18 (22.2%) | 15 |
| White blood cell decrease | 3/18 (16.7%) | 7 |
| Alkaline phosphatase increase | 3/18 (16.7%) | 3 |
| Creatinine increased | 3/18 (16.7%) | 3 |
| Blood bilirubin increase | 2/18 (11.1%) | 2 |
| Activated partial thromb | 1/18 (5.6%) | 1 |
| Aspartate aminotransfera | 1/18 (5.6%) | 1 |
| Investigations - Other | 1/18 (5.6%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypophosphatemia | 5/18 (27.8%) | 7 |
| Hypocalcemia | 5/18 (27.8%) | 6 |
| Anorexia | 5/18 (27.8%) | 5 |
| Hypoalbuminemia | 5/18 (27.8%) | 5 |
| Hyperglycemia | 3/18 (16.7%) | 3 |
| Hypomagnesemia | 3/18 (16.7%) | 3 |
| Hypokalemia | 2/18 (11.1%) | 4 |
| Dehydration | 1/18 (5.6%) | 1 |
| Hypermagnesemia | 1/18 (5.6%) | 1 |
| Metabolism and nutrition | 1/18 (5.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 3/18 (16.7%) | 4 |
| Flank pain | 3/18 (16.7%) | 3 |
| Pain in extremity | 2/18 (11.1%) | 2 |
| Bone pain | 1/18 (5.6%) | 2 |
| Arthralgia | 1/18 (5.6%) | 1 |
| Muscle weakness lower limb | 1/18 (5.6%) | 1 |
| Muscle weakness upper limb | 1/18 (5.6%) | 1 |
| Myalgia | 1/18 (5.6%) | 1 |
| Nervous system disorders | ||
| Anxiety | 2/18 (11.1%) | 2 |
| Peripheral sensory neuro | 2/18 (11.1%) | 2 |
| Dysgeusia | 1/18 (5.6%) | 1 |
| Headache | 1/18 (5.6%) | 1 |
| Myelitis | 1/18 (5.6%) | 1 |
| Nervous system disorders | 1/18 (5.6%) | 1 |
| Paresthesia | 1/18 (5.6%) | 1 |
| Peripheral motor neuropa | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||
| Insomnia | 1/18 (5.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 10/18 (55.6%) | 11 |
| Pleural effusion | 1/18 (5.6%) | 2 |
| Epistaxis | 1/18 (5.6%) | 1 |
| Hoarseness | 1/18 (5.6%) | 1 |
| Sore throat | 1/18 (5.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Skin and subcutaneous tissue disorder | 1/18 (5.6%) | 2 |
| Vascular disorders | ||
| Vascular disorders - Oth | 2/18 (11.1%) | 2 |
| Hematoma | 1/18 (5.6%) | 1 |
| Hypertension | 1/18 (5.6%) | 1 |
| Hypotension | 1/18 (5.6%) | 1 |
| Thromboembolic event | 1/18 (5.6%) | 1 |
Limitations/Caveats
[Not Specified]
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 | Jeremy Abramson, MD |
|---|---|
| Organization | Massachusetts General Hospital Cancer Center |
| Phone | 617-724-4000 |
| jabramson@mgh.harvard.edu |
Responsible Party:
Jeremy Abramson, MD,
Director, Lymphoma Program,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01282476
Other Study ID Numbers:
- 10-441
First Posted:
Jan 25, 2011
Last Update Posted:
May 9, 2017
Last Verified:
Apr 1, 2017