Ibrutinib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT02219737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2018-01-26
Summary
This phase I trial studies the side effects and best dose of ibrutinib when given together with rituximab, ifosfamide, carboplatin, and etoposide (combination chemotherapy) in treating patients with diffuse large B-cell lymphoma (DLBCL) that has returned after a period of improvement (relapsed) or has not responded to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, rituximab, ifosfamide, carboplatin, and etoposide, 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 ibrutinib together with combination chemotherapy may be a better treatment for patients with relapsed or refractory DLBCL.
Conditions
- CD20 Positive
- Recurrent Diffuse Large B-Cell Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
Given IVPB
- DRUG
-
Etoposide
Given IVPB
- DRUG
-
Given PO
- DRUG
-
Ifosfamide
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Craig Sauter · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-12
- Primary Completion
- 2017-05-11
- Completion
- 2017-05-11
Countries
- United States
Study Locations
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