Status:
WITHDRAWN
Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate when given together with rituximab and bendamustine hydrochloride to see how well it works compared with ritu...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of the combination of obatoclax mesylate, rituximab, and bendamustine hydrochloride in patients w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma (NHL), including any of the following subtypes recognized by WHO classification:
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Transformed lymphoma from a low-grade, indolent NHL allowed provided patient has received ≥ 1 prior therapy for indolent disease
- Must have received ≥ 1 prior therapy
- Relapsed disease after autologous or allogeneic stem cell transplantation (SCT) allowed (phase I)
- No relapse after allogeneic SCT (phase II)
- No known CNS lymphoma
- ECOG performance status 0-2
- ANC ≥ 1,000/µL
- Platelet count ≥ 50,000/µL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception prior to and for the duration of study participation
- No active hepatitis B infection
- Patients with a history of hepatitis B (surface antigen or core antibody positive) must take lamivudine or equivalent during study therapy
- No history of documented human anti-globulin antibodies, or a history of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine hydrochloride, or obatoclax mesylate
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness and/or social situations that would limit compliance with study requirements
- HIV infection allowed provided patient meets the following criteria:
- No evidence of co-infection with hepatitis B or C
- CD4 cell count ≥ 400/mm³
- No evidence of resistant strains of HIV
- HIV viral load ≤ 10,000 copies HIV RNA/mL for patients not on anti-HIV combination antiretroviral therapy OR HIV viral load ≤ 50,000 copies HIV RNA/mL for patients on anti-HIV therapy
- No history of AIDS-defining conditions
- No active secondary malignancy except for non-melanomatous skin cancer
- No other concurrent investigational agents
- Prior bendamustine hydrochloride allowed provided patient has completed a bendamustine-containing regimen within the past 6 months and achieved a partial response or better
- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01238146
Start Date
October 1 2010
Last Update
June 6 2013
Active Locations (1)
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1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210