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OpenTrials
Completed

NCT Number: NCT00427856

Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)

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.

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Key information

Conditions

Lymphoma, Follicular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

About this study

This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathological confirmation of Follicular Lymphoma (FL)
  • Must have advanced stage disease
  • Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
  • Must have adequate 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
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding

Treatment and study plan

Obatoclax mesylate

Drug

Obatoclax mesylate 40mg, and 60mg

Other names: (GX15-070MS)

Rituximab

Drug

Rituximab

Primary outcomes

  1. Response rate

    Time frame: 12 weeks

Secondary outcomes

  1. Time to Tumor Progression.

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Gemin X

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2007
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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