Refractory Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
A Phase I Study Combining Ibrutinib With Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients With Relapsed or Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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.
PRIMARY OBJECTIVES:
I. Safety of ibrutinib in combination with rituximab-ifosfamide, carboplatin, and etoposide
(R-ICE).
II. Establishment of maximum tolerated dose of ibrutinib with R-ICE.
SECONDARY OBJECTIVES:
I. Pharmacokinetic (PK) studies of ibrutinib in combination with R-ICE. II. Clinical response
rate of ibrutinib+R-ICE.
OUTLINE: This is a dose-escalation study of ibrutinib.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-21, rituximab intravenously
(IV) on day 1, ifosfamide IV on day 3, carboplatin intravenously piggy back (IVPB) on day 3,
and etoposide IVPB on days 2-4. Treatment repeats every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 52 weeks.
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