Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407303

Enrollment

Registered

2006-12-05

Start date

2006-10-31

Completion date

2009-11-30

Last updated

2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle-Cell Lymphoma

Brief summary

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Detailed description

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.

Interventions

DRUGObatoclax mesylate

30 mg, 45 mg

DRUGBortezomib

1.0mg/m2, 1.3 mg/m2

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile	4 weeks to 2 years

Secondary

Measure	Time frame
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements	4 weeks to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026