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NCT00171249 · ClinicalTrials.gov registry record · Phase 2
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 293
- Enrollment target
- 12
- Study locations
NCT00171249 is a Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 293 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (155% higher). The trial reports 12 study locations across 5 states.
The verdict
NCT00171249, a Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 293 participants
- Enrollment target
- 12
- Study locations
Study Summary
The objectives of Part 1 of the study were: * To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). * To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment. The objective of the extension (Part 2) was: -To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
Conditions Studied
Interventions
- DRUG STI571 400 mg
- DRUG STI571 600 mg
Study Locations (12)
Other
- Novartis Investigative Site - Pessac
- Novartis Investigative Site - Poitiers
- Novartis Investigative Site - Frankfurt
- Novartis Investigative Site - Leipzig
- Novartis Investigative Site - Mainz
- Novartis Investigative Site - Mannheim
- Novartis Investigative Site - Monza
- Novartis Investigative Site - London
Massachusetts
- Dana Faber Cancer Institute - Boston
New York
- New York Presbyterian Hospital - New York
Oregon
- Oregon Health & Sciences University - Portland
Texas
- MD Anderson Cancer Center, University of Texas - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 1999-08-09 |
| Est. Completion | 2013-09-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00171249
The ClinicalTrials.gov registry entry for NCT00171249 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 293 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (155% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which STI571 400 mg is the first listed.
NCT00171249 reports 12 study locations spanning 5 distinct geographic areas - top geographies include Other, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT00171249 about?
NCT00171249 is a clinical study titled "An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia". The objectives of Part 1 of the study were: * To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). * To evaluate duration of HR, overall survival, cytogenetic res...
What is the current status of trial NCT00171249?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 293 participants. The study started on 1999-08-09. Estimated completion is 2013-09-23.
What conditions does trial NCT00171249 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Philadelphia Positive Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT00171249?
The interventions under investigation include: STI571 400 mg (DRUG), STI571 600 mg (DRUG).
Who is sponsoring clinical trial NCT00171249?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00171249 being conducted?
This trial has 12 study locations across Massachusetts, New York, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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