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NCT00373529 · ClinicalTrials.gov registry record · Phase 2
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
A Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
- 20
- Study locations
NCT00373529: Completed Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia, sponsored by Genzyme, a Sanofi Company.
NCT00373529 is a Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 116 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00373529, a Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
- 20
- Study locations
Study Summary
Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.
Primary Outcome
Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with impro
Conditions Studied
Interventions
- DRUG clofarabine
Study Locations (20)
Arizona
- Mayo Clinical Hospital - Phoenix
- Arizona Cancer Center - Tucson
California
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Scripps Cancer Center - San Diego
Georgia
- Emory University School of Medicine - Atlanta
- Medical College of Georgia - Augusta
Texas
- University of MD Anderson Cancer Center - Houston
- Cancer Care Centers of South Texas - San Antonio
Colorado
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Cancer Center of Central Connecticut - Southington
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00373529 record still lists
NCT00373529 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target.
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which clofarabine is the first listed.
NCT00373529 names 20 study sites across 16 states, led by Arizona, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00373529 about?
NCT00373529 is a clinical study titled "A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)". Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in e...
What is the current status of trial NCT00373529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2006-10. Estimated completion is 2010-05.
What conditions does trial NCT00373529 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00373529?
The interventions under investigation include: clofarabine (DRUG).
Who is sponsoring clinical trial NCT00373529?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00373529 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00373529's enrollment target sits among peer trials
116 70th of 306 higher than 236 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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