Maintenance Lenalidomide in Lymphoma
|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: NCT01575860|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Lenalidomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Lenalidomide Therapy After Autologous Stem Cell Transplant in Patients With High Risk Relapsed/Refractory Lymphomas|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 30, 2018|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Phase I/II (Maintenance Lenalidomide in Lymphoma)
Total of 24 cycles of lenalidomide. Subjects received a starting daily dose of 10mg lenalidomide on days 1 through 28 of each 28 day cycle. Subjects initiated lenalidomide 28-100 days post-ASCT.
Lenalidomide, 10mg, oral tablets, daily
Other Name: Revlimid, CC-5013
- Number of Subjects With Dose-limiting Toxicities [ Time Frame: 28 days (Cycle 1) ]Dose-limiting toxicity (DLT) is defined as any grade 3 toxicity or higher that occurs during the first 28 days of therapy and is possibly, probably, or definitely related to lenalidomide maintenance.
- Progression Free Survival [ Time Frame: 12 months from start of lenalidomide maintenance ]Progression free survival (PFS) is defined as days from start of high dose chemotherapy to first documented progression of disease, death due to any cause or last patient contact.
- Overall Survival [ Time Frame: 12 months from the start of lenalidomide maintenance ]Overall survival (OS) is defined as days from start of high dose chemotherapy to death due to any cause or last patient contact.
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): NCT01575860
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jakub Svoboda, MD||Abramson Cancer Center of the University of Pennsylvania|