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slow accrual
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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panobinostat/Rituximab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat with Rituximab | Drug | 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 | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate | Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). | 6 months |
| Toxicities | Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy S Abramson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17242396 | Background | Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | 90% Confidence Interval | percentage of participants | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Abramson, MD | Massachusetts General Hospital Cancer Center | 617-724-4000 | jabramson@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| 1 year |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | 8 from DFCI, 10 from MGH | Number | participants |
|
| Histology | Count of Participants | Participants |
|
| EKG (electrocardiogram) | Count of Participants | Participants |
|
| elevated LDH (Lactate dehydrogenase) | Count of Participants | Participants |
|
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) | Count of Participants | Participants |
|
| Disease status | Count of Participants | Participants |
|
| Number of extranodal sites | Count of Participants | Participants |
|
| Number of target lesions | Count of Participants | Participants |
|
| Number of non-target lesions | Count of Participants | Participants |
|
| Time from last prior therapy | Median | Full Range | days |
|
| Number of prior therapies | Count of Participants | Participants |
|
| Number of prior non-surgical therapies | Count of Participants | Participants |
|
| Number of prior surgeries | Count of Participants | Participants |
|
| Number of prior radiation treatments | Count of Participants | Participants |
|
|
| Secondary | Progression-free Survival Rate | Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 10 |
| 18 |
| 18 |
| 18 |
| Bilateral Deep Vein Thrombosis | Vascular disorders |
|
| Death | General disorders |
|
| Death from disease progression | Blood and lymphatic system disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Headache | General disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypophosphatemia | Metabolism and nutrition disorders |
|
| Hypotension | Cardiac disorders |
|
| Leukocytopenia | Blood and lymphatic system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Pain (back) | General disorders |
|
| Right lower extremity cellulitis | Infections and infestations |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders |
|
| Syncope | Nervous system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Fatigue | General disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Lymphocyte count decrease | Investigations |
|
| Nausea | Gastrointestinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Hypophosphatemia | Metabolism and nutrition disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Hypoalbuminemia | Metabolism and nutrition disorders |
|
| Neutrophil count decrease | Investigations |
|
| Constipation | Gastrointestinal disorders |
|
| Edema limbs | General disorders |
|
| White blood cell decrease | Investigations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Alkaline phosphatase increase | Investigations |
|
| Creatinine increased | Investigations |
|
| Flank pain | Musculoskeletal and connective tissue disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hypomagnesemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Anxiety | Nervous system disorders |
|
| Blood bilirubin increase | Investigations |
|
| Pain | General disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Peripheral sensory neuro | Nervous system disorders |
|
| Vascular disorders - Oth | Vascular disorders |
|
| Bone pain | Musculoskeletal and connective tissue disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Skin and subcutaneous tissue disorder | Skin and subcutaneous tissue disorders |
|
| Activated partial thromb | Investigations |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Aspartate aminotransfera | Investigations |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Edema face | General disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Fever | General disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Gastroesophageal reflux | Gastrointestinal disorders |
|
| General disorders | General disorders |
|
| Headache | Nervous system disorders |
|
| Hematoma | Vascular disorders |
|
| Hepatobiliary disorders | Hepatobiliary disorders |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders |
|
| Hypermagnesemia | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypotension | Vascular disorders |
|
| Infusion related reaction | General disorders |
|
| Insomnia | Psychiatric disorders |
|
| Investigations - Other | Investigations |
|
| Metabolism and nutrition | Metabolism and nutrition disorders |
|
| Mucositis oral | Gastrointestinal disorders |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Myelitis | Nervous system disorders |
|
| Myocarditis | Cardiac disorders |
|
| Nervous system disorders | Nervous system disorders |
|
| Non-cardiac chest pain | General disorders |
|
| Paresthesia | Nervous system disorders |
|
| Peripheral motor neuropa | Nervous system disorders |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders |
|
| Thromboembolic event | Vascular disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Vomiting | Gastrointestinal disorders |
|
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Did not have any |
|
| Fatigue |
|
| Anemia |
|
| Diarrhea |
|
| Nausea |
|
| Lymphocyte count decreased |
|
| Anorexia |
|
| Hypophosphatemia |
|
| Neutrophil count decreased |
|
| Hypoalbuminemia |
|
| Dyspnea |
|
| Constipation |
|
| Alkaline phosphatase increased |
|
| Creatinine increased |
|
| White blood cell decreased |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hypomagnesemia |
|
| Dry mouth |
|
| Flatulence |
|
| Gatstroesophageal reflux disease |
|
| Mucositis oral |
|
| Vomiting |
|
| Edema face |
|
| Edema limbs |
|
| Fever |
|
| Hepatobiliary disorders - other |
|
| Aspartate aminotransferase increased |
|
| Blood bilirubin increased |
|
| Metabolism and nutrition disorders - other |
|
| Bone pain |
|
| Dysgeusia |
|
| Headache |
|
| Insomnia |
|
| Epistaxis |
|
| Skin and subcutaneous tissue disorders - other |
|