Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
Part of paid clinical trials in Houston, Texas.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00023920
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Blastic Phase Chronic Myelogenous Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICALGiven IV
- idarubicin — DRUGGiven IV
- cytarabine — DRUGGiven SC
Study Details
This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia
Key Dates
- First listed
- Jan 27, 2003
- Start date
- Jul 31, 2001
- Status verified
- Jan 2013
- Primary completion
- Sep 30, 2004
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (bevacizumab, idarubicin, cytarabine)Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Improvement in response rate [ Time Frame: Up to 3 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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