Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02341014|
Recruitment Status : Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|T-cell Lymphomas Relapsed or Refractory||Drug: Carfilzomib Drug: Romidepsin Drug: Lenalidomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/IIa Study of Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Carfilzomib, Romidepsin, Lenalidomide
All patients will be treated with romidepsin administered intravenously on days 1 and 8 of a 21-day cycle. Lenalidomide will be taken orally daily for days 1-14 of a 21-day cycle. The carfilzomib will be given weekly on days 1, and 8 of a 21-day cycle. Once a MTD is determined this dosing level will be used for the phase IIa portion. Cycles will be continued as above until the patient's wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.
The initial dose of carfilzomib (cycle 1, day 1) given to any patient regardless of dose level must be 20mg/m2 . All subsequent doses of carfilzomib will be based on the patient's dose level.
- MTD (phase Ib) [ Time Frame: 1 year ]Determine the MTD by NCI-CTCAE v4.0.
- overall response rate (orr) [ Time Frame: 1 year ]will be summarized using proportions and confidence intervals will be provided. ORR will be calculated based on the best response at any time during the course of treatment on this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341014
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-7680|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Principal Investigator:||Steven Horwitz, MD||Memorial Sloan Kettering Cancer Center|