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NCT00634244 · ClinicalTrials.gov registry record · Phase 2
Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 20
- Study locations
NCT00634244: Completed Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).
NCT00634244 is a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, below the 116-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634244, a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial is comparing three different combination chemotherapy regimens to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with relapsed or refractory acute myeloid leukemia.
Primary Outcome
CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CR
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG sirolimus
- DRUG cytarabine
- DRUG alvocidib
- DRUG mitoxantrone hydrochloride
Study Locations (20)
Pennsylvania
- Geisinger Medical Center - Danville
- Geisinger Medical Center-Cancer Center Hazleton - Hazleton
- Penn State Milton S Hershey Medical Center - Hershey
- Lewistown Hospital - Lewistown
- Geisinger Medical Group - State College
- Mount Nittany Medical Center - State College
- Geisinger Wyoming Valley - Wilkes-Barre
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
- Froedtert and the Medical College of Wisconsin - Milwaukee
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Illinois
- Northwestern University - Chicago
Iowa
- Siouxland Hematology Oncology Associates - Sioux City
Maryland
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT00634244 record still lists
NCT00634244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 116-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (21% lower).
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT00634244 names 20 study sites across 13 states, led by Pennsylvania, Wisconsin, Alabama.
Frequently Asked Questions
What is clinical trial NCT00634244 about?
NCT00634244 is a clinical study titled "Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This randomized phase II trial is comparing three different combination chemotherapy regimens to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the...
What is the current status of trial NCT00634244?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2008-10. Estimated completion is 2014-10.
What conditions does trial NCT00634244 study?
This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Minimally Differentiated Myeloid Leukemia (M0).
What interventions are being tested in trial NCT00634244?
The interventions under investigation include: carboplatin (DRUG), sirolimus (DRUG), cytarabine (DRUG), alvocidib (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00634244?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00634244 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00634244's enrollment target sits among peer trials
92 7th of 29 higher than 23 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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