Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT01076543|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2010
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|AIDS-Related Hodgkin Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Follicular Lymphoma Recurrent Lymphoplasmacytic Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Non-Hodgkin Lymphoma Recurrent T-Cell Non-Hodgkin Lymphoma Waldenstrom Macroglobulinemia||Other: Laboratory Biomarker Analysis Drug: Lenalidomide Drug: Temsirolimus||Phase 1 Phase 2|
I. To determine the safety, toxicity, and maximum tolerated dose of lenalidomide when combined with temsirolimus in patients with relapsed lymphomas. (Phase I) II. To determine complete and overall response rate of lenalidomide plus temsirolimus in patients with relapsed lymphomas as stratified by histology: follicular lymphoma, diffuse large B-cell lymphoma, and lymphoma not otherwise specified (NOS) (including Hodgkin lymphoma, T-cell non-Hodgkin lymphoma [T-NHL], lymphoplasmacytic lymphoma, and mantle cell lymphoma). (Phase II) III. To determine duration of response, progression-free survival, and overall survival of lenalidomide plus temsirolimus in patients with relapsed lymphomas as stratified by histology: diffuse large B-cell lymphoma, follicular lymphoma, and lymphoma NOS (including Hodgkin lymphoma, T-NHL, lymphoplasmacytic lymphoma, mantle cell lymphoma). (Phase II)
I. To determine mammalian target of rapamycin (mTOR) pathway activation in pre-treatment tumor tissue.
II. To determine angiogenic and microenvironmental status of pre-treatment tissue and peripheral blood samples, and to evaluate changes following treatment with temsirolimus and lenalidomide.
III. To determine differentially expressed genes associated with differences in clinical response and in progression-free survival (PFS) in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (Groups A and B, respectively).
IV. To determine a methylation signature predictive of clinical response and PFS in patients with DLBCL and FL (Groups A and B, respectively).
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.
Patients receive lenalidomide orally (PO) on days 1-21 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses may continue therapy for up to 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Investigation of Temsirolimus Plus Lenalidomide in Relapsed Non-Hodgkin Lymphomas|
|Actual Study Start Date :||April 15, 2010|
|Actual Primary Completion Date :||December 31, 2017|
Experimental: Treatment (lenalidomide, temsirolimus)
Patients receive lenalidomide PO on days 1-21 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses may continue therapy for up to 52 weeks.
Other: Laboratory Biomarker Analysis
- Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: 28 days ]
- Maximum-tolerated dose based on the incidence of DLT as graded by the NCI CTCAE version 4.0 (Phase I) [ Time Frame: 28 days ]
- Complete response (Phase II) [ Time Frame: Up to 1 year ]
- Overall response rate (Phase II) [ Time Frame: Up to 1 year ]
- Progression-free survival (PFS) (Phase II) [ Time Frame: Time from study entry until disease progression or death from any cause, assessed up to 1 year ]Kaplan-Meier curves will be generated for PFS stratified by histology; median PFS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.
- Overall survival (OS) (Phase II) [ Time Frame: Time from study entry until death from any cause, assessed up to 1 year ]Kaplan-Meier curves will be generated for OS stratified by histology; median OS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076543
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Peoria, Illinois, United States, 61615|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62702|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc-Parkview|
|Fort Wayne, Indiana, United States, 46845|
|Indiana University/Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Missouri|
|Mercy Hospital Saint Louis|
|Saint Louis, Missouri, United States, 63141|
|Principal Investigator:||Sonali Smith||University of Chicago Comprehensive Cancer Center|