Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 rituximab and bendamustine hydrochloride alone in treating patients with relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and bendamustine hydrochloride may kill more cancer cells

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bendamustine Hydrochloride; Obatoclax; Rituximab

Criteria

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