Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)
|ClinicalTrials.gov Identifier: NCT01120834|
Recruitment Status : Completed
First Posted : May 11, 2010
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: azacytidine Drug: vorinostat||Phase 1 Phase 2|
Eligible subjects will have biopsy proven relapsed or refractory DLBCL, have preserved hematologic and other organ function, and have either progressed following or be inappropriate candidates for autologous stem cell transplantation.
Patients will be treated with 5-azacitidine via subcutaneous administration and vorinostat orally at four different dose levels as described below:
- Dose level 1: azacitidine 55 mg/m2 on days 1-5 and oral vorinostat at 300 mg BID on Days 1-7.
- Dose level 2: azacitidine 75 mg/m2 on days 1-5 and oral vorinostat at 200 mg BID on Days 1-7.
- Dose level 3: azacitidine 55 mg/m2 on days 1-5 and oral vorinostat at 300 mg BID on Days 1-14.
- Dose level 4: azacitidine 75 mg/m2 on days 1-5 and oral vorinostat at 200 mg BID on Days 1-14.
Each cycle will be of 28 days and patients will be treated for up to 6 cycles.
Up to 8 patients will be enrolled at each dose level. If at any time 2 patients in a given cohort experience DLT, enrollment to that level will be discontinued.
Efficacy will be assessed by standard radiographic and other criteria at baseline and at the end of treatment to determine ORR. Patients will be followed for 2 years or until disease progression.
Tumor samples will be obtained for correlative studies at baseline through core needle or surgical biopsy, with an additional biopsy performed on day 15 of cycle 1 as a pharmacodynamic endpoint.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory DLBCL|
|Actual Study Start Date :||September 2010|
|Primary Completion Date :||April 2013|
|Study Completion Date :||October 20, 2016|
|Experimental: all subjects||
Each cycle = 28 days. Subjects may receive up to 6 cycles.
Each cycle = 28 days. Subjects receive up to 6 cycles.
- Overall Response Rate (ORR) [ Time Frame: 2 cycles ]Overall Response Rate (ORR)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120834
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter Martin, MD||Weill Medical College of Cornell University|