Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Genta Incorporated
Study ID
NCT00078234
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oblimersen-rituximab-fludarabine — DRUG
    28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab

Study Details

The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.

Key Dates

Start date
Nov 30, 2003
Status verified
May 2009
Primary completion
Sep 30, 2008
Completion
Sep 30, 2010

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Safety and complete response rate [ Time Frame: Monthly for response ]

Locations (3)

FacilityCityStateZIPSite coordinators
Georgetown University Medical Center/Lombardi Cancer CenterWashington D.C.District of Columbia20007-
Roswell Park Cancer InstituteBuffaloNew York14263-
Long Island Jewish Medical CenterNew Hyde ParkNew York11040-

Find similar trials in Washington D.C., DC

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Georgetown University Medical Center/Lombardi Cancer Center· Washington D.C., DCRoswell Park Cancer Institute· Buffalo, NYLong Island Jewish Medical Center· New Hyde Park, NY

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