Diffuse Large B Cell Lymphoma
Conditions
Keywords
DLBCL (Diffuse Large B Cell Lymphoma), Panobinostat, LBH589 (Panobinostat), LBH-589 (Panobinostat), HDAC inhibitor (Histone deacetylase inhibitor), DAC inhibitor (deacetylase inhibitor), deacetylase inhibitor, lymphoma
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.
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.
Interventions
DRUGPanobinostat 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.
Sponsors
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 11 |
Baseline characteristics
| Characteristic | Panobinostat/Rituximab |
|---|---|
| Age, Continuous | 68 years |
| Disease status Refractory | 10 Participants |
| Disease status Relapsed | 8 Participants |
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) 00-Fully Active | 7 Participants |
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) 01-Restricted | 8 Participants |
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) 02-Ambulatory and Capable of Self Care | 3 Participants |
| EKG (electrocardiogram) Abnormal | 3 Participants |
| EKG (electrocardiogram) Normal | 15 Participants |
| elevated LDH (Lactate dehydrogenase) Missing | 6 Participants |
| elevated LDH (Lactate dehydrogenase) No | 3 Participants |
| elevated LDH (Lactate dehydrogenase) Yes | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Histology Centroblastic DLBCL(Diffuse large B cell lymphoma) | 1 Participants |
| Histology DLBCL follicular cell derivation w/high grade BCL | 1 Participants |
| Histology DLBCL not otherwise specified | 14 Participants |
| Histology DLBCL of follicular center derivation | 1 Participants |
| Histology Gray zone lymphoma | 1 Participants |
| Number of extranodal sites 0 | 1 Participants |
| Number of extranodal sites 1 | 3 Participants |
| Number of extranodal sites 2 | 3 Participants |
| Number of extranodal sites 3 | 9 Participants |
| Number of extranodal sites 6 | 2 Participants |
| Number of non-target lesions 0-2 | 12 Participants |
| Number of non-target lesions 3-5 | 4 Participants |
| Number of non-target lesions 6+ | 2 Participants |
| Number of prior non-surgical therapies 0-2 | 6 Participants |
| Number of prior non-surgical therapies 3-5 | 7 Participants |
| Number of prior non-surgical therapies 6-8 | 5 Participants |
| Number of prior radiation treatments 0 | 12 Participants |
| Number of prior radiation treatments 1 | 3 Participants |
| Number of prior radiation treatments 2 | 2 Participants |
| Number of prior radiation treatments 3 | 1 Participants |
| Number of prior surgeries 0 | 12 Participants |
| Number of prior surgeries 1 | 2 Participants |
| Number of prior surgeries 2 | 2 Participants |
| Number of prior surgeries 3 | 1 Participants |
| Number of prior surgeries 4 | 1 Participants |
| Number of prior therapies 1-4 | 7 Participants |
| Number of prior therapies 5-8 | 9 Participants |
| Number of prior therapies 9+ | 2 Participants |
| Number of target lesions 0-2 | 4 Participants |
| Number of target lesions 3-5 | 6 Participants |
| Number of target lesions 6+ | 8 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
| Time from last prior therapy | 117 days |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 10 / 18 |
Outcome results
Primary
Overall Response Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panobinostat/Rituximab | Overall Response Rate | 11 percentage of participants |
Secondary
Progression-free Survival Rate
Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panobinostat/Rituximab | Progression-free Survival Rate | 6 percentage of participants |
Secondary
Toxicities
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Panobinostat/Rituximab | Toxicities | Constipation | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Diarrhea | Grade 1 | 5 Participants |
| Panobinostat/Rituximab | Toxicities | Diarrhea | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Diarrhea | Grade 3 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Diarrhea | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Diarrhea | Did not have any | 10 Participants |
| Panobinostat/Rituximab | Toxicities | Neutrophil count decreased | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Neutrophil count decreased | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Neutrophil count decreased | Grade 3 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Dyspnea | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dyspnea | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dyspnea | Did not have any | 14 Participants |
| Panobinostat/Rituximab | Toxicities | Constipation | Grade 1 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Constipation | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypocalcemia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypocalcemia | Did not have any | 15 Participants |
| Panobinostat/Rituximab | Toxicities | Hypokalemia | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypokalemia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypokalemia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Headache | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Insomnia | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Insomnia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Insomnia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Insomnia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Insomnia | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Epistaxis | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Epistaxis | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Anemia | Did not have any | 8 Participants |
| Panobinostat/Rituximab | Toxicities | Platelet count decreased | Grade 1 | 5 Participants |
| Panobinostat/Rituximab | Toxicities | Platelet count decreased | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Platelet count decreased | Grade 3 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Platelet count decreased | Grade 4 | 7 Participants |
| Panobinostat/Rituximab | Toxicities | Platelet count decreased | Did not have any | 4 Participants |
| Panobinostat/Rituximab | Toxicities | Fatigue | Grade 1 | 7 Participants |
| Panobinostat/Rituximab | Toxicities | Fatigue | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Fatigue | Grade 3 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Fatigue | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Fatigue | Did not have any | 7 Participants |
| Panobinostat/Rituximab | Toxicities | Anemia | Grade 1 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Anemia | Grade 2 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Anemia | Grade 3 | 4 Participants |
| Panobinostat/Rituximab | Toxicities | Anemia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Nausea | Grade 1 | 5 Participants |
| Panobinostat/Rituximab | Toxicities | Nausea | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Nausea | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Nausea | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Nausea | Did not have any | 13 Participants |
| Panobinostat/Rituximab | Toxicities | Lymphocyte count decreased | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Lymphocyte count decreased | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Lymphocyte count decreased | Grade 3 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Lymphocyte count decreased | Grade 4 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Lymphocyte count decreased | Did not have any | 13 Participants |
| Panobinostat/Rituximab | Toxicities | Anorexia | Grade 1 | 4 Participants |
| Panobinostat/Rituximab | Toxicities | Anorexia | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Anorexia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Anorexia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Anorexia | Did not have any | 13 Participants |
| Panobinostat/Rituximab | Toxicities | Hypophosphatemia | Grade 1 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Hypophosphatemia | Grade 2 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Hypophosphatemia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypophosphatemia | Grade 4 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Hypophosphatemia | Did not have any | 13 Participants |
| Panobinostat/Rituximab | Toxicities | Neutrophil count decreased | Grade 4 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Neutrophil count decreased | Did not have any | 14 Participants |
| Panobinostat/Rituximab | Toxicities | Hypoalbuminemia | Grade 1 | 4 Participants |
| Panobinostat/Rituximab | Toxicities | Hypoalbuminemia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypoalbuminemia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypoalbuminemia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypoalbuminemia | Did not have any | 14 Participants |
| Panobinostat/Rituximab | Toxicities | Dyspnea | Grade 1 | 4 Participants |
| Panobinostat/Rituximab | Toxicities | Dyspnea | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Constipation | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Constipation | Did not have any | 15 Participants |
| Panobinostat/Rituximab | Toxicities | Alkaline phosphatase increased | Grade 1 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Alkaline phosphatase increased | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Alkaline phosphatase increased | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Alkaline phosphatase increased | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Alkaline phosphatase increased | Did not have any | 15 Participants |
| Panobinostat/Rituximab | Toxicities | Creatinine increased | Grade 1 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Creatinine increased | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Creatinine increased | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Creatinine increased | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Creatinine increased | Did not have any | 15 Participants |
| Panobinostat/Rituximab | Toxicities | White blood cell decreased | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | White blood cell decreased | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | White blood cell decreased | Grade 3 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | White blood cell decreased | Grade 4 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | White blood cell decreased | Did not have any | 15 Participants |
| Panobinostat/Rituximab | Toxicities | Hypocalcemia | Grade 1 | 3 Participants |
| Panobinostat/Rituximab | Toxicities | Hypocalcemia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypocalcemia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypokalemia | Grade 4 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Hypokalemia | Did not have any | 16 Participants |
| Panobinostat/Rituximab | Toxicities | Hypomagnesemia | Grade 1 | 2 Participants |
| Panobinostat/Rituximab | Toxicities | Hypomagnesemia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypomagnesemia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypomagnesemia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hypomagnesemia | Did not have any | 16 Participants |
| Panobinostat/Rituximab | Toxicities | Dry mouth | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Dry mouth | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dry mouth | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dry mouth | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dry mouth | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Flatulence | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Flatulence | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Flatulence | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Flatulence | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Flatulence | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Gatstroesophageal reflux disease | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Gatstroesophageal reflux disease | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Gatstroesophageal reflux disease | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Gatstroesophageal reflux disease | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Gatstroesophageal reflux disease | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Mucositis oral | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Mucositis oral | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Mucositis oral | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Mucositis oral | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Mucositis oral | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Vomiting | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Vomiting | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Vomiting | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Vomiting | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Vomiting | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Edema face | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Edema face | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema face | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema face | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema face | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Edema limbs | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Edema limbs | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema limbs | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema limbs | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Edema limbs | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Fever | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Fever | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Fever | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Fever | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Epistaxis | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Fever | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Hepatobiliary disorders - other | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hepatobiliary disorders - other | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hepatobiliary disorders - other | Grade 3 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Hepatobiliary disorders - other | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Hepatobiliary disorders - other | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Aspartate aminotransferase increased | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Aspartate aminotransferase increased | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Aspartate aminotransferase increased | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Aspartate aminotransferase increased | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Aspartate aminotransferase increased | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Blood bilirubin increased | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Blood bilirubin increased | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Blood bilirubin increased | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Blood bilirubin increased | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Blood bilirubin increased | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Metabolism and nutrition disorders - other | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Metabolism and nutrition disorders - other | Grade 2 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Metabolism and nutrition disorders - other | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Metabolism and nutrition disorders - other | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Metabolism and nutrition disorders - other | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Bone pain | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Bone pain | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Bone pain | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Bone pain | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Bone pain | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Dysgeusia | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Dysgeusia | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dysgeusia | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dysgeusia | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Dysgeusia | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Headache | Grade 1 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Headache | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Headache | Grade 3 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Headache | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Epistaxis | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Epistaxis | Did not have any | 17 Participants |
| Panobinostat/Rituximab | Toxicities | Skin and subcutaneous tissue disorders - other | Grade 1 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Skin and subcutaneous tissue disorders - other | Grade 2 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Skin and subcutaneous tissue disorders - other | Grade 3 | 1 Participants |
| Panobinostat/Rituximab | Toxicities | Skin and subcutaneous tissue disorders - other | Grade 4 | 0 Participants |
| Panobinostat/Rituximab | Toxicities | Skin and subcutaneous tissue disorders - other | Did not have any | 17 Participants |