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A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle-Cell Lymphoma

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Trial Information

A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)


This is a multi-center, open-label, Phase I study of Obatoclax administered in combination
with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell
Lymphoma. Treatment may be administered on an outpatient basis. No investigational or
commercial agents or therapies other than those described herein may be administered with
the intent to treat the patients's malignancy. Supportive care measures including those
directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.


Inclusion Criteria:



- Pathological confirmation of Mantle Cell Lymphoma (ML)

- Must have documented relapse or progression following 1 or 2 prior lines of
antineoplastic therapy

- Must have normal organ function

- Must have the ability to understand and willingness to sign a written informed
consent form

Exclusion Criteria:

- No other agents or therapies administered with the intent to treat malignancy

- Patients with prior exposure to obatoclax

- Uncontrolled, intercurrent illness

- Pregnant women and women who are breast feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile

Outcome Time Frame:

4 weeks to 2 years

Safety Issue:

Yes

Principal Investigator

Jean Viallet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM012

NCT ID:

NCT00407303

Start Date:

October 2006

Completion Date:

November 2009

Related Keywords:

  • Mantle-Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
University of WisconsinMadison,, Wisconsin  53792-5666
NW Georgia Oncology CentersMarietta, Georgia  30060
Roswell Park Medical CenterBuffalo, New York  14263