Trial Outcomes & Findings for Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (NCT NCT01282476)
NCT ID: NCT01282476
Last Updated: 2017-05-09
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-09
Participant Flow
Participant milestones
| Measure |
Panobinostat/Rituximab
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 Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Panobinostat/Rituximab
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 Study
Death
|
11
|
Baseline Characteristics
Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Panobinostat/Rituximab
n=18 Participants
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.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Histology
Centroblastic DLBCL(Diffuse large B cell lymphoma)
|
1 Participants
n=5 Participants
|
|
Histology
DLBCL follicular cell derivation w/high grade BCL
|
1 Participants
n=5 Participants
|
|
Histology
DLBCL not otherwise specified
|
14 Participants
n=5 Participants
|
|
Histology
DLBCL of follicular center derivation
|
1 Participants
n=5 Participants
|
|
Histology
Gray zone lymphoma
|
1 Participants
n=5 Participants
|
|
EKG (electrocardiogram)
Abnormal
|
3 Participants
n=5 Participants
|
|
EKG (electrocardiogram)
Normal
|
15 Participants
n=5 Participants
|
|
elevated LDH (Lactate dehydrogenase)
Yes
|
9 Participants
n=5 Participants
|
|
elevated LDH (Lactate dehydrogenase)
No
|
3 Participants
n=5 Participants
|
|
elevated LDH (Lactate dehydrogenase)
Missing
|
6 Participants
n=5 Participants
|
|
ECOG PS (Eastern Cooperative Oncology Group Performance Status)
00-Fully Active
|
7 Participants
n=5 Participants
|
|
ECOG PS (Eastern Cooperative Oncology Group Performance Status)
01-Restricted
|
8 Participants
n=5 Participants
|
|
ECOG PS (Eastern Cooperative Oncology Group Performance Status)
02-Ambulatory and Capable of Self Care
|
3 Participants
n=5 Participants
|
|
Disease status
Refractory
|
10 Participants
n=5 Participants
|
|
Disease status
Relapsed
|
8 Participants
n=5 Participants
|
|
Number of extranodal sites
0
|
1 Participants
n=5 Participants
|
|
Number of extranodal sites
1
|
3 Participants
n=5 Participants
|
|
Number of extranodal sites
2
|
3 Participants
n=5 Participants
|
|
Number of extranodal sites
3
|
9 Participants
n=5 Participants
|
|
Number of extranodal sites
6
|
2 Participants
n=5 Participants
|
|
Number of target lesions
0-2
|
4 Participants
n=5 Participants
|
|
Number of target lesions
3-5
|
6 Participants
n=5 Participants
|
|
Number of target lesions
6+
|
8 Participants
n=5 Participants
|
|
Number of non-target lesions
0-2
|
12 Participants
n=5 Participants
|
|
Number of non-target lesions
3-5
|
4 Participants
n=5 Participants
|
|
Number of non-target lesions
6+
|
2 Participants
n=5 Participants
|
|
Time from last prior therapy
|
117 days
n=5 Participants
|
|
Number of prior therapies
1-4
|
7 Participants
n=5 Participants
|
|
Number of prior therapies
5-8
|
9 Participants
n=5 Participants
|
|
Number of prior therapies
9+
|
2 Participants
n=5 Participants
|
|
Number of prior non-surgical therapies
0-2
|
6 Participants
n=5 Participants
|
|
Number of prior non-surgical therapies
3-5
|
7 Participants
n=5 Participants
|
|
Number of prior non-surgical therapies
6-8
|
5 Participants
n=5 Participants
|
|
Number of prior surgeries
0
|
12 Participants
n=5 Participants
|
|
Number of prior surgeries
1
|
2 Participants
n=5 Participants
|
|
Number of prior surgeries
2
|
2 Participants
n=5 Participants
|
|
Number of prior surgeries
3
|
1 Participants
n=5 Participants
|
|
Number of prior surgeries
4
|
1 Participants
n=5 Participants
|
|
Number of prior radiation treatments
0
|
12 Participants
n=5 Participants
|
|
Number of prior radiation treatments
1
|
3 Participants
n=5 Participants
|
|
Number of prior radiation treatments
2
|
2 Participants
n=5 Participants
|
|
Number of prior radiation treatments
3
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOverall 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)
Outcome measures
| Measure |
Panobinostat/Rituximab
n=18 Participants
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 Response Rate
|
11 percentage of participants
Interval 2.0 to 31.0
|
SECONDARY outcome
Timeframe: 6 monthsProgression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
Outcome measures
| Measure |
Panobinostat/Rituximab
n=18 Participants
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.
|
|---|---|
|
Progression-free Survival Rate
|
6 percentage of participants
Interval 0.7 to 21.0
|
SECONDARY outcome
Timeframe: 1 yearEvaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening
Outcome measures
| Measure |
Panobinostat/Rituximab
n=18 Participants
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.
|
|---|---|
|
Toxicities
Dyspnea · Grade 3
|
0 Participants
|
|
Toxicities
Hypokalemia · Did not have any
|
16 Participants
|
|
Toxicities
Hypomagnesemia · Grade 1
|
2 Participants
|
|
Toxicities
Skin and subcutaneous tissue disorders - other · Did not have any
|
17 Participants
|
|
Toxicities
Hypomagnesemia · Did not have any
|
16 Participants
|
|
Toxicities
Edema face · Grade 4
|
0 Participants
|
|
Toxicities
Edema face · Did not have any
|
17 Participants
|
|
Toxicities
Edema limbs · Grade 1
|
1 Participants
|
|
Toxicities
Edema limbs · Grade 2
|
0 Participants
|
|
Toxicities
Edema limbs · Grade 3
|
0 Participants
|
|
Toxicities
Edema limbs · Grade 4
|
0 Participants
|
|
Toxicities
Edema limbs · Did not have any
|
17 Participants
|
|
Toxicities
Fever · Grade 1
|
0 Participants
|
|
Toxicities
Fever · Grade 2
|
1 Participants
|
|
Toxicities
Fever · Grade 3
|
0 Participants
|
|
Toxicities
Fever · Grade 4
|
0 Participants
|
|
Toxicities
Fever · Did not have any
|
17 Participants
|
|
Toxicities
Hepatobiliary disorders - other · Grade 1
|
0 Participants
|
|
Toxicities
Hepatobiliary disorders - other · Grade 2
|
0 Participants
|
|
Toxicities
Platelet count decreased · Grade 1
|
5 Participants
|
|
Toxicities
Platelet count decreased · Grade 2
|
1 Participants
|
|
Toxicities
Platelet count decreased · Grade 3
|
1 Participants
|
|
Toxicities
Platelet count decreased · Grade 4
|
7 Participants
|
|
Toxicities
Platelet count decreased · Did not have any
|
4 Participants
|
|
Toxicities
Fatigue · Grade 1
|
7 Participants
|
|
Toxicities
Fatigue · Grade 2
|
1 Participants
|
|
Toxicities
Fatigue · Grade 3
|
3 Participants
|
|
Toxicities
Fatigue · Grade 4
|
0 Participants
|
|
Toxicities
Fatigue · Did not have any
|
7 Participants
|
|
Toxicities
Anemia · Grade 1
|
3 Participants
|
|
Toxicities
Anemia · Grade 2
|
3 Participants
|
|
Toxicities
Anemia · Grade 3
|
4 Participants
|
|
Toxicities
Anemia · Grade 4
|
0 Participants
|
|
Toxicities
Anemia · Did not have any
|
8 Participants
|
|
Toxicities
Diarrhea · Grade 1
|
5 Participants
|
|
Toxicities
Diarrhea · Grade 2
|
1 Participants
|
|
Toxicities
Diarrhea · Grade 3
|
2 Participants
|
|
Toxicities
Diarrhea · Grade 4
|
0 Participants
|
|
Toxicities
Diarrhea · Did not have any
|
10 Participants
|
|
Toxicities
Nausea · Grade 1
|
5 Participants
|
|
Toxicities
Nausea · Grade 2
|
0 Participants
|
|
Toxicities
Nausea · Grade 3
|
0 Participants
|
|
Toxicities
Nausea · Grade 4
|
0 Participants
|
|
Toxicities
Nausea · Did not have any
|
13 Participants
|
|
Toxicities
Lymphocyte count decreased · Grade 1
|
0 Participants
|
|
Toxicities
Lymphocyte count decreased · Grade 2
|
1 Participants
|
|
Toxicities
Lymphocyte count decreased · Grade 3
|
3 Participants
|
|
Toxicities
Lymphocyte count decreased · Grade 4
|
1 Participants
|
|
Toxicities
Lymphocyte count decreased · Did not have any
|
13 Participants
|
|
Toxicities
Anorexia · Grade 1
|
4 Participants
|
|
Toxicities
Anorexia · Grade 2
|
1 Participants
|
|
Toxicities
Anorexia · Grade 3
|
0 Participants
|
|
Toxicities
Anorexia · Grade 4
|
0 Participants
|
|
Toxicities
Anorexia · Did not have any
|
13 Participants
|
|
Toxicities
Hypophosphatemia · Grade 1
|
2 Participants
|
|
Toxicities
Hypophosphatemia · Grade 2
|
2 Participants
|
|
Toxicities
Hypophosphatemia · Grade 3
|
0 Participants
|
|
Toxicities
Hypophosphatemia · Grade 4
|
1 Participants
|
|
Toxicities
Hypophosphatemia · Did not have any
|
13 Participants
|
|
Toxicities
Neutrophil count decreased · Grade 1
|
0 Participants
|
|
Toxicities
Neutrophil count decreased · Grade 2
|
1 Participants
|
|
Toxicities
Neutrophil count decreased · Grade 3
|
2 Participants
|
|
Toxicities
Neutrophil count decreased · Grade 4
|
1 Participants
|
|
Toxicities
Neutrophil count decreased · Did not have any
|
14 Participants
|
|
Toxicities
Hypoalbuminemia · Grade 1
|
4 Participants
|
|
Toxicities
Hypoalbuminemia · Grade 2
|
0 Participants
|
|
Toxicities
Hypoalbuminemia · Grade 3
|
0 Participants
|
|
Toxicities
Hypoalbuminemia · Grade 4
|
0 Participants
|
|
Toxicities
Hypoalbuminemia · Did not have any
|
14 Participants
|
|
Toxicities
Dyspnea · Grade 1
|
4 Participants
|
|
Toxicities
Dyspnea · Grade 2
|
0 Participants
|
|
Toxicities
Dyspnea · Grade 4
|
0 Participants
|
|
Toxicities
Dyspnea · Did not have any
|
14 Participants
|
|
Toxicities
Constipation · Grade 1
|
3 Participants
|
|
Toxicities
Constipation · Grade 2
|
0 Participants
|
|
Toxicities
Constipation · Grade 3
|
0 Participants
|
|
Toxicities
Constipation · Grade 4
|
0 Participants
|
|
Toxicities
Constipation · Did not have any
|
15 Participants
|
|
Toxicities
Alkaline phosphatase increased · Grade 1
|
3 Participants
|
|
Toxicities
Alkaline phosphatase increased · Grade 2
|
0 Participants
|
|
Toxicities
Alkaline phosphatase increased · Grade 3
|
0 Participants
|
|
Toxicities
Alkaline phosphatase increased · Grade 4
|
0 Participants
|
|
Toxicities
Alkaline phosphatase increased · Did not have any
|
15 Participants
|
|
Toxicities
Hepatobiliary disorders - other · Grade 3
|
1 Participants
|
|
Toxicities
Hepatobiliary disorders - other · Grade 4
|
0 Participants
|
|
Toxicities
Hepatobiliary disorders - other · Did not have any
|
17 Participants
|
|
Toxicities
Aspartate aminotransferase increased · Grade 1
|
1 Participants
|
|
Toxicities
Aspartate aminotransferase increased · Grade 2
|
0 Participants
|
|
Toxicities
Aspartate aminotransferase increased · Grade 3
|
0 Participants
|
|
Toxicities
Aspartate aminotransferase increased · Grade 4
|
0 Participants
|
|
Toxicities
Aspartate aminotransferase increased · Did not have any
|
17 Participants
|
|
Toxicities
Blood bilirubin increased · Grade 1
|
1 Participants
|
|
Toxicities
Blood bilirubin increased · Grade 2
|
0 Participants
|
|
Toxicities
Blood bilirubin increased · Grade 3
|
0 Participants
|
|
Toxicities
Blood bilirubin increased · Grade 4
|
0 Participants
|
|
Toxicities
Blood bilirubin increased · Did not have any
|
17 Participants
|
|
Toxicities
Metabolism and nutrition disorders - other · Grade 1
|
0 Participants
|
|
Toxicities
Metabolism and nutrition disorders - other · Grade 2
|
1 Participants
|
|
Toxicities
Metabolism and nutrition disorders - other · Grade 3
|
0 Participants
|
|
Toxicities
Metabolism and nutrition disorders - other · Grade 4
|
0 Participants
|
|
Toxicities
Metabolism and nutrition disorders - other · Did not have any
|
17 Participants
|
|
Toxicities
Bone pain · Grade 1
|
1 Participants
|
|
Toxicities
Bone pain · Grade 2
|
0 Participants
|
|
Toxicities
Bone pain · Grade 3
|
0 Participants
|
|
Toxicities
Bone pain · Grade 4
|
0 Participants
|
|
Toxicities
Bone pain · Did not have any
|
17 Participants
|
|
Toxicities
Dysgeusia · Grade 1
|
1 Participants
|
|
Toxicities
Dysgeusia · Grade 2
|
0 Participants
|
|
Toxicities
Dysgeusia · Grade 3
|
0 Participants
|
|
Toxicities
Dysgeusia · Grade 4
|
0 Participants
|
|
Toxicities
Dysgeusia · Did not have any
|
17 Participants
|
|
Toxicities
Headache · Grade 1
|
1 Participants
|
|
Toxicities
Headache · Grade 2
|
0 Participants
|
|
Toxicities
Headache · Grade 3
|
0 Participants
|
|
Toxicities
Headache · Grade 4
|
0 Participants
|
|
Toxicities
Headache · Did not have any
|
17 Participants
|
|
Toxicities
Insomnia · Grade 1
|
1 Participants
|
|
Toxicities
Insomnia · Grade 2
|
0 Participants
|
|
Toxicities
Insomnia · Grade 3
|
0 Participants
|
|
Toxicities
Insomnia · Grade 4
|
0 Participants
|
|
Toxicities
Insomnia · Did not have any
|
17 Participants
|
|
Toxicities
Epistaxis · Grade 1
|
1 Participants
|
|
Toxicities
Epistaxis · Grade 2
|
0 Participants
|
|
Toxicities
Epistaxis · Grade 3
|
0 Participants
|
|
Toxicities
Epistaxis · Grade 4
|
0 Participants
|
|
Toxicities
Epistaxis · Did not have any
|
17 Participants
|
|
Toxicities
Skin and subcutaneous tissue disorders - other · Grade 1
|
0 Participants
|
|
Toxicities
Skin and subcutaneous tissue disorders - other · Grade 2
|
0 Participants
|
|
Toxicities
Skin and subcutaneous tissue disorders - other · Grade 3
|
1 Participants
|
|
Toxicities
Creatinine increased · Grade 1
|
3 Participants
|
|
Toxicities
Creatinine increased · Grade 2
|
0 Participants
|
|
Toxicities
Creatinine increased · Grade 3
|
0 Participants
|
|
Toxicities
Creatinine increased · Grade 4
|
0 Participants
|
|
Toxicities
Creatinine increased · Did not have any
|
15 Participants
|
|
Toxicities
White blood cell decreased · Grade 1
|
0 Participants
|
|
Toxicities
White blood cell decreased · Grade 2
|
0 Participants
|
|
Toxicities
White blood cell decreased · Grade 3
|
2 Participants
|
|
Toxicities
White blood cell decreased · Grade 4
|
1 Participants
|
|
Toxicities
White blood cell decreased · Did not have any
|
15 Participants
|
|
Toxicities
Hypocalcemia · Grade 1
|
3 Participants
|
|
Toxicities
Hypocalcemia · Grade 2
|
0 Participants
|
|
Toxicities
Hypocalcemia · Grade 3
|
0 Participants
|
|
Toxicities
Hypocalcemia · Grade 4
|
0 Participants
|
|
Toxicities
Hypocalcemia · Did not have any
|
15 Participants
|
|
Toxicities
Hypokalemia · Grade 1
|
0 Participants
|
|
Toxicities
Hypokalemia · Grade 2
|
0 Participants
|
|
Toxicities
Skin and subcutaneous tissue disorders - other · Grade 4
|
0 Participants
|
|
Toxicities
Hypokalemia · Grade 3
|
0 Participants
|
|
Toxicities
Hypokalemia · Grade 4
|
2 Participants
|
|
Toxicities
Hypomagnesemia · Grade 2
|
0 Participants
|
|
Toxicities
Hypomagnesemia · Grade 3
|
0 Participants
|
|
Toxicities
Hypomagnesemia · Grade 4
|
0 Participants
|
|
Toxicities
Dry mouth · Grade 1
|
1 Participants
|
|
Toxicities
Dry mouth · Grade 2
|
0 Participants
|
|
Toxicities
Dry mouth · Grade 3
|
0 Participants
|
|
Toxicities
Dry mouth · Grade 4
|
0 Participants
|
|
Toxicities
Dry mouth · Did not have any
|
17 Participants
|
|
Toxicities
Flatulence · Grade 1
|
1 Participants
|
|
Toxicities
Flatulence · Grade 2
|
0 Participants
|
|
Toxicities
Flatulence · Grade 3
|
0 Participants
|
|
Toxicities
Flatulence · Grade 4
|
0 Participants
|
|
Toxicities
Flatulence · Did not have any
|
17 Participants
|
|
Toxicities
Gatstroesophageal reflux disease · Grade 1
|
1 Participants
|
|
Toxicities
Gatstroesophageal reflux disease · Grade 2
|
0 Participants
|
|
Toxicities
Gatstroesophageal reflux disease · Grade 3
|
0 Participants
|
|
Toxicities
Gatstroesophageal reflux disease · Grade 4
|
0 Participants
|
|
Toxicities
Gatstroesophageal reflux disease · Did not have any
|
17 Participants
|
|
Toxicities
Mucositis oral · Grade 1
|
1 Participants
|
|
Toxicities
Mucositis oral · Grade 2
|
0 Participants
|
|
Toxicities
Mucositis oral · Grade 3
|
0 Participants
|
|
Toxicities
Mucositis oral · Grade 4
|
0 Participants
|
|
Toxicities
Mucositis oral · Did not have any
|
17 Participants
|
|
Toxicities
Vomiting · Grade 1
|
1 Participants
|
|
Toxicities
Vomiting · Grade 2
|
0 Participants
|
|
Toxicities
Vomiting · Grade 3
|
0 Participants
|
|
Toxicities
Vomiting · Grade 4
|
0 Participants
|
|
Toxicities
Vomiting · Did not have any
|
17 Participants
|
|
Toxicities
Edema face · Grade 1
|
1 Participants
|
|
Toxicities
Edema face · Grade 2
|
0 Participants
|
|
Toxicities
Edema face · Grade 3
|
0 Participants
|
Adverse Events
Panobinostat/Rituximab
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panobinostat/Rituximab
n=18 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Bilateral Deep Vein Thrombosis
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Death
|
16.7%
3/18 • Number of events 3
|
|
Blood and lymphatic system disorders
Death from disease progression
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Headache
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain (back)
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Right lower extremity cellulitis
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
6/18 • Number of events 6
|
Other adverse events
| Measure |
Panobinostat/Rituximab
n=18 participants at risk
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.
|
|---|---|
|
Investigations
Platelet count decreased
|
66.7%
12/18 • Number of events 30
|
|
General disorders
Fatigue
|
72.2%
13/18 • Number of events 24
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
12/18 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
55.6%
10/18 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18 • Number of events 10
|
|
Investigations
Lymphocyte count decrease
|
38.9%
7/18 • Number of events 19
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
6/18 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.8%
5/18 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.8%
5/18 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
27.8%
5/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.8%
5/18 • Number of events 5
|
|
Investigations
Neutrophil count decrease
|
22.2%
4/18 • Number of events 15
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • Number of events 6
|
|
General disorders
Edema limbs
|
22.2%
4/18 • Number of events 4
|
|
Investigations
White blood cell decrease
|
16.7%
3/18 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
3/18 • Number of events 4
|
|
Investigations
Alkaline phosphatase increase
|
16.7%
3/18 • Number of events 3
|
|
Investigations
Creatinine increased
|
16.7%
3/18 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Number of events 4
|
|
Nervous system disorders
Anxiety
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Blood bilirubin increase
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Pain
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuro
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Vascular disorders - Oth
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Activated partial thromb
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Aspartate aminotransfera
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Edema face
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
5.6%
1/18 • Number of events 1
|
|
General disorders
General disorders
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hematoma
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Infusion related reaction
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Investigations - Other
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and nutrition
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Myelitis
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Myocarditis
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropa
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
Additional Information
Jeremy Abramson, MD
Massachusetts General Hospital Cancer Center
Phone: 617-724-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place