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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: Completed Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
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 |
What the finished NCT00171249 record still lists
NCT00171249 is an interventional study that assigns participants to a tested intervention. The registered 293 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (155% higher).
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 lists 12 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT00171249's enrollment target sits among peer trials
293 28th of 306 higher than 279 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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