Lenalidomide as Maintenance Therapy After Combination Chemotherapy With or Without Rituximab and Stem Cell Transplant in Treating Patients With Persistent or Recurrent Non-Hodgkin Lymphoma That is Resistant to Chemotherapy

This study is currently recruiting participants.
Verified March 2011 by University of Nebraska

First Received on December 17, 2009.  
Last Updated on March 8, 2011  
History of Changes
This Clinical Trial Sponsored By: University of Nebraska
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT01035463
 

Purpose for Clinical Trial

RATIONALE: 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, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase I/II trial is studying 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 persistent or recurrent non-Hodgkin lymphoma that is resistant to chemotherapy

Condition Study Intervention Clinical Trial Phase
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic Lymphadenopathy
Mucosa-Associated Lymphoid Tissue Lymphoma
Monocytoid B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt’s Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Cutaneous T-cell Lymphoma Recurrent
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Recurrent
Recurrent Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Recurrent
B-cell Small Lymphocytic Lymphoma Recurrent
Splenic Marginal Zone B-Cell Lymphoma
Stage III Adult Burkitt’s Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Cutaneous T-cell Lymphoma Stage III
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Stage III
Stage III Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Stage III
B-cell Small Lymphocytic Lymphoma Stage III
Stage IV Adult Burkitt’s Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Cutaneous T-cell Lymphoma Stage IV
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Stage IV
Stage IV Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Stage IV
B-cell Small Lymphocytic Lymphoma Stage IV
Waldenstrom Macroglobulinemia
Drug: lenalidomide
Biological: rituximab
Procedure: autologous hematopoietic stem cell transplantation
Drug: carmustine
Drug: etoposide
Drug: cytarabine
Drug: melphalan
Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Lenalidomide Maintenance Following BEAM (+/- Rituximab) for Chemo-Resistant or High Risk Non-Hodgkin’s Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Lymphoma
Drug Information available for:
Cytarabine
Melphalan
Carmustine
Melphalan hydrochloride
Etoposide
Etoposide phosphate
Rituximab
Lenalidomide

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures For Clinical Trial:

  • MTD (Phase I) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity (DLT) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • Event-free survival (Phase II) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival (Phase II) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Complete response rate (Phase II) [ Time Frame: At 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: November 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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