Lenalidomide and Ipilimumab Post Allo or Auto Stem Cell Transplantation (SCT)
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|ClinicalTrials.gov Identifier: NCT01919619|
Recruitment Status : Recruiting
First Posted : August 9, 2013
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Blood And Marrow Transplantation Leukemia Lymphoma||Drug: Lenalidomide Drug: Ipilimumab||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Lenalidomide Alternating With Ipilimumab Post Allogeneic and Autologous Stem Cell Transplantation|
|Actual Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Lenalidomide + Ipilimumab
Patients receive lenalidomide by mouth alternating with ipilimumab for 4 cycles (lenalidomide for 21 days, then one dose of ipilimumab, then repeat lenalidomide 4 weeks later, etc.) Ipilimumab is fixed at 3 mg/kg and given by vein. One dose of ipilimumab (Cycle 2) given within 1-3 days from the last day of lenalidomide, then followed by 4 weeks of rest. Lenalidomide repeated daily for 21 days (Cycle 3) followed by one dose of ipilimumab (Cycle 4) within 1-3 days from the last dose of lenalidomide. Treatment repeated for a total of 8 cycles.
If creatinine clearance greater than 60 mL/min starting dose of Lenalidomide: 10 mg by mouth daily for 21 days (followed by 7 rest days).
If creatinine clearance 30 to 60 mL/min starting dose of Lenalidomide: 5 mg by mouth daily for 21 days (followed by 7 rest days),
Ipilimumab 3 mg/kg by vein. One dose of ipilimumab (Cycle 2) given within 1-3 days from the last day of lenalidomide, then followed by 4 weeks of rest. Lenalidomide repeated daily for 21 days (Cycle 3) followed by one dose of ipilimumab (Cycle 4) within 1-3 days from the last dose of lenalidomide. Treatment repeated for a total of 8 cycles.
- Toxicity Rate [ Time Frame: 28 days ]Each transplant group (either autologous or allogeneic) will be monitored separately for toxicity. Toxicity includes any grade III or IV toxicity requiring a drug hold of more than 2 weeks within the first four cycles that does not resolve with dose reduction or any acute grade III or higher GVHD within 100 days.
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): NCT01919619
|Contact: Issa F. Khouri, MD, BSemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issa F. Khouri, MD, BS||M.D. Anderson Cancer Center|