NCT01035463

Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma

Phase I/II Study of Lenalidomide Maintenance Following BEAM (+/- Rituximab) for Chemo-Resistant or High Risk Non-Hodgkin?s Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of lenalidomide when given after combination chemotherapy with or without rituximab and stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma that has not responded to treatment or has returned after a period of improvement and is resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving lenalidomide after combination chemotherapy with or without rituximab may work better in treating patients with non-Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of lenalidomide given in the post-transplant setting for a 12 month maintenance period. SECONDARY OBJECTIVES: I. To obtain preliminary estimates of the 1-year response rate, event-free and overall survival using this regimen. OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. PRE-CONDITIONING (patients with cluster of differentiation \[CD\]20+ non-Hodgkin lymphoma): Patients receive rituximab intravenously (IV) per standard of care. PREPARATIVE REGIMEN: Patients receive carmustine IV on day -6, etoposide IV twice daily (BID) and cytarabine IV BID on days -5 through -2, and melphalan IV on day -1. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Negative
• Recurrent Anaplastic Large Cell Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo autologous hematopoietic stem cell transplant
DRUG	Carmustine	Given IV
DRUG	Cytarabine	Given IV
DRUG	Etoposide	Given IV
DRUG	Lenalidomide	Given PO
DRUG	Melphalan	Given IV
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2009-11-12
• Primary completion: 2017-07-27
• Completion: 2018-07-27
• First posted: 2009-12-18
• Last updated: 2023-10-10
• Results posted: 2019-11-08

Locations

3 sites across 1 country: United States