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Sponsored by: |
Genta Incorporated |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024440 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may help fludarabine and cyclophosphamide kill more cancer cells by making them more sensitive to the drugs. It is not yet known if fludarabine and cyclophosphamide are more effective with or without oblimersen.
PURPOSE: Randomized phase III trial to compare the effectiveness of fludarabine and cyclophosphamide with or without oblimersen in treating patients who have relapsed or refractory chronic lymphocytic leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: oblimersen |
Phase III |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Cyclophosphamide Filgrastim Fludarabine Fludarabine monophosphate Oblimersen sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense (Bcl-2 Antisense Oligonucleotide) In Subjects With Relapsed Or Refractory Chronic Lymphocytic Leukemia |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease response to prior fludarabine-containing therapy (responsive vs refractory), number of prior regimens (1-2 vs 3 or more), and duration of response to last prior therapy (more than 6 months vs 6 months or fewer). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) requiring therapy
Intermediate or high-risk CLL
Intermediate-risk disease must satisfy at least 1 of the following criteria for active disease:
Massive or progressive splenomegaly and/or lymphadenopathy
Measurable disease with all of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068932, GENTA-GL303, UCLA-0104008 |
First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024440 |
Health Authority: | United States: Federal Government |
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