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A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)


Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending
doses.


Inclusion Criteria:



- Histologically or cytologically confirmed B-CLL

- Previous standard systemic chemotherapy, including fludarabine. There are no
limitations on additional, allowable type and amount of prior therapy. Acute
toxicities from prior therapy must have resolved to ≤Grade 1

- Age ≥18 years

- ECOG Performance Status ≤1

- Life expectancy of >8 weeks

Exclusion Criteria:

- Patients receiving any other investigational agents (e.g., under another IND) or
commercial agents or therapies administered with the intent to treat their malignancy

- Patients with history of seizure disorders

- Pregnant women and women who are breast feeding

- HIV-positive patients receiving combination anti-retroviral therapy

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 recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks

Outcome Time Frame:

14 days

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:

GX004

NCT ID:

NCT00600964

Start Date:

September 2004

Completion Date:

January 2006

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • obatoclax
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Lombardi Cancer CenterWashington, District of Columbia  20007
UT MD Anderson Cancer CenterHouston, Texas  77030
University of CA- San DiegoLa Jolla, California  92093
Milton S Hershey Medical Center Penn State Cancer InstituteHershey, Pennsylvania  17033