R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
NCT02628405 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-07-01
Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) and that has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better treatment for patients with diffuse large B-cell lymphoma.
Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent Transformed Non-Hodgkin Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Refractory Transformed Non-Hodgkin Lymphoma
Interventions
- DRUG
-
Given IV
- DRUG
-
Etoposide
Given IV
- DRUG
-
Ifosfamide
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Academic and Community Cancer Research United
lead OTHER
Principal Investigators
-
Grzegorz S Nowakowski · Academic and Community Cancer Research United
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-20
- Primary Completion
- 2021-09-24
- Completion
- 2025-12-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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