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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01238146
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bendamustine hydrochloride — DRUG
    Given IV
  • obatoclax mesylate — DRUG
    Given IV
  • rituximab — BIOLOGICAL
    Given IV

Study Details

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

Key Dates

Start date
Oct 31, 2010
Status verified
Jun 2013
Primary completion
Apr 30, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: Arm II
    Patients receive rituximab and bendamustine hydrochloride as in arm I.

Primary Outcome Measure

Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I) [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center· Columbus, OH

Related Studies