Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00553202 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT00553202: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00553202 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 158 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553202, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening. PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting leukemia. Bone marrow donors can be selected based on the type of NK cells they have, specifically the killer immunoglobulin receptor (KIR) type. This study provides information on KIR type from potential donors, which can be used in selecting the bone marrow donor. This phase II trial of unrelated donor stem cell transplant in patients with high risk AML (monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of the patients and potential donors will be available to the treating transplant physician at the time of donor selection.
Primary Outcome
OS - Time from HSCT until death
Interventions
- DRUG cyclophosphamide
- DRUG methotrexate
- DRUG busulfan
- DRUG cyclosporine
- BIOLOGICAL anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2008-01 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 2 |
What the finished NCT00553202 record still lists
NCT00553202 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00553202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553202 about?
NCT00553202 is a clinical study titled "Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia". RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's im...
What is the current status of trial NCT00553202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2008-01. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT00553202?
The interventions under investigation include: cyclophosphamide (DRUG), methotrexate (DRUG), busulfan (DRUG), cyclosporine (DRUG), anti-thymocyte globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00553202?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553202's enrollment target sits among peer trials
158 443rd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04486833 · 158 participants · Phase 1
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
- NCT04697966 · 158 participants · NA
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
- NCT04969835 · 158 participants · Phase 1
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
- NCT05230732 · 158 participants · NA
Neuromodulation of Inflammation and Endothelial Function
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia