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NCT00322101 · ClinicalTrials.gov registry record · Phase 3
Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
A Phase 3 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 8
- Study locations
NCT00322101: Completed Phase 3 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Fred Hutchinson Cancer Center.
NCT00322101 is a Phase 3 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 Fred Hutchinson Cancer Center. The registered enrollment target is 25 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00322101, a Phase 3 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 8
- Study locations
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia. PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Conditions Studied
Interventions
- DRUG cyclophosphamide
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- DRUG busulfan
- RADIATION total-body irradiation
- DRUG mycophenolate mofetil
Study Locations (8)
Washington
- Veterans Administration Center-Seattle - Seattle
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Colorado
- HealthOne Presbyterian St. Lukes Medical Center - Denver
Georgia
- Emory University - Altanta
New York
- Weill Cornell University - New York
Utah
- University of Utah - Salt Lake City
Wisconsin
- Medical College Wisconsin - Milwaukee
Saxony
- Technical University Dresden - Dresden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00322101 record still lists
NCT00322101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (79% 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 cyclophosphamide is the first listed.
NCT00322101 lists 8 locations in 7 states (Washington, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT00322101 about?
NCT00322101 is a clinical study titled "Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia". RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Wh...
What is the current status of trial NCT00322101?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2006-01. Estimated completion is 2014-10.
What conditions does trial NCT00322101 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(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22).
What interventions are being tested in trial NCT00322101?
The interventions under investigation include: cyclophosphamide (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), busulfan (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00322101?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00322101 being conducted?
This trial has 8 study locations across Colorado, Georgia, New York, Utah, Washington. 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 NCT00322101's enrollment target sits among peer trials
25 22nd of 29 higher than 8 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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