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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01238146
Other study ID # NCI-2011-02536
Secondary ID OSU-10040U01CA07
Status Withdrawn
Phase Phase 1/Phase 2
First received November 9, 2010
Last updated June 5, 2013
Start date October 2010

Study information

Verified date June 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

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Intervention

Drug:
bendamustine hydrochloride
Given IV
obatoclax mesylate
Given IV
Biological:
rituximab
Given IV

Locations

Country Name City State
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I) 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. 28 days Yes
Primary Change in median progression-free survival (PFS) (phase II) Estimated using the method of Kaplan-Meier. From 6 to 12 months No
Secondary Overall objective response rate (phase II) 95% confidence intervals will be provided. Up to 3 years No
Secondary PFS (phase II) Estimated using the method of Kaplan-Meier. From the date of start of therapy to disease progression or death, whichever occurs first, assessed at 2 years No
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