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NCT00544466 · ClinicalTrials.gov registry record · Phase 1
Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies
A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00544466: Active Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by City of Hope Medical Center.
NCT00544466 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 75 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00544466, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening. PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.
Primary Outcome
Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Conditions Studied
Interventions
- RADIATION intensity-modulated radiation therapy
- DRUG fludarabine phosphate
- DRUG melphalan
- PROCEDURE allogeneic hematopoietic stem cell transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-07-31 |
| Est. Completion | 2026-12-02 |
| Phase | Phase 1 |
What the registry record for NCT00544466 still lists
NCT00544466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 4 interventions - of which intensity-modulated radiation therapy is the first listed.
NCT00544466 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00544466 about?
NCT00544466 is a clinical study titled "Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies". RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infu...
What is the current status of trial NCT00544466?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2006-07-31. Estimated completion is 2026-12-02.
What conditions does trial NCT00544466 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT00544466?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), fludarabine phosphate (DRUG), melphalan (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00544466?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00544466 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00544466's enrollment target sits among peer trials
75 85th of 233 higher than 148 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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