Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238146
Recruitment Status : Withdrawn (No patients accrued.)
First Posted : November 10, 2010
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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 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

Condition or disease Intervention/treatment Phase
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Splenic Marginal Zone Lymphoma Drug: bendamustine hydrochloride Drug: obatoclax mesylate Biological: rituximab Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Rituximab, Bendamustine, and Obatoclax in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Study Start Date : October 2010
Actual Primary Completion Date : April 2012

Arm Intervention/treatment
Experimental: Arm I
Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2.
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda

Drug: obatoclax mesylate
Given IV
Other Name: GX15-070MS

Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • Rituxan

Experimental: Arm II
Patients receive rituximab and bendamustine hydrochloride as in arm I.
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda

Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • Rituxan

Primary Outcome Measures :
  1. Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I) [ Time Frame: 28 days ]
    Graded using CTCAE version 4 criteria. DLTs are defined as grade 3-4 neutropenia or thrombocytopenia that persists beyond day 42; grade 4 febrile neutropenia or infection; grade 3 febrile neutropenia or infection that fails to resolve within 7days, grade 3-4 somnolence, ataxia, or confusion that requires inpatient admission on day 1 for observation and prevents patient discharge from outpatient clinic, or other grade 3-4 non-hematologic toxicity excluding infection.

  2. Change in median progression-free survival (PFS) (phase II) [ Time Frame: From 6 to 12 months ]
    Estimated using the method of Kaplan-Meier.

Secondary Outcome Measures :
  1. Overall objective response rate (phase II) [ Time Frame: Up to 3 years ]
    95% confidence intervals will be provided.

  2. PFS (phase II) [ Time Frame: From the date of start of therapy to disease progression or death, whichever occurs first, assessed at 2 years ]
    Estimated using the method of Kaplan-Meier.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238146

Layout table for location information
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Elizabeth Christian Ohio State University Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT01238146    
Other Study ID Numbers: NCI-2011-02536
U01CA076576 ( U.S. NIH Grant/Contract )
CDR0000687197 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors