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NCT00070499 · ClinicalTrials.gov registry record · Phase 2
Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
A Phase 2 study of Chronic Myeloid Leukemia, BCR-ABL1 Positive, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT00070499: Active Phase 2 study of Chronic Myeloid Leukemia, BCR-ABL1 Positive, sponsored by National Cancer Institute (NCI).
NCT00070499 is a Phase 2 study of Chronic Myeloid Leukemia, BCR-ABL1 Positive that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 406 participants, above the 98-participant average among 4 other Chronic Myeloid Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (314% higher). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00070499, a Phase 2 study of Chronic Myeloid Leukemia, BCR-ABL1 Positive, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Dasatinib
- DRUG Imatinib Mesylate
Study Locations (20)
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fremont - Fremont
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Redwood City - Redwood City
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente Sacramento Medical Center - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser Permanente-San Rafael - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
- Kaiser Permanente-South San Francisco - South San Francisco
- Kaiser Permanente-Stockton - Stockton
- Kaiser Permanente-Vallejo - Vallejo
- Kaiser Permanente-Walnut Creek - Walnut Creek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2004-08-15 |
| Est. Completion | 2026-03-10 |
| Phase | Phase 2 |
What the registry record for NCT00070499 still lists
NCT00070499 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, above the 98-participant average among 4 other Chronic Myeloid Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (314% higher).
The record links to 1 condition, with Chronic Myeloid Leukemia, BCR-ABL1 Positive appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00070499 names 20 study sites across 1 states, led by California.
Frequently Asked Questions
What is clinical trial NCT00070499 about?
NCT00070499 is a clinical study titled "Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia". This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of t...
What is the current status of trial NCT00070499?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 406 participants. The study started on 2004-08-15. Estimated completion is 2026-03-10.
What conditions does trial NCT00070499 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT00070499?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dasatinib (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00070499?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00070499 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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