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NCT00576979 · ClinicalTrials.gov registry record · Phase 1
Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
A Phase 1 study of Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT00576979: Active Phase 1 study of Leukemia, sponsored by City of Hope Medical Center.
NCT00576979 is a Phase 1 study of Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 51 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576979, a Phase 1 study of Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, 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 IMRT together with chemotherapy before transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Primary Outcome
Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG etoposide
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- PROCEDURE peripheral blood stem cell transplantation
- PROCEDURE allogeneic bone marrow transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-03-04 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 1 |
What the registry record for NCT00576979 still lists
NCT00576979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00576979 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00576979 about?
NCT00576979 is a clinical study titled "Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia". RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, 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 s...
What is the current status of trial NCT00576979?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2008-03-04. Estimated completion is 2026-02-03.
What conditions does trial NCT00576979 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00576979?
The interventions under investigation include: cyclophosphamide (DRUG), etoposide (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE), allogeneic bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00576979?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00576979 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00576979's enrollment target sits among peer trials
51 111th of 233 higher than 123 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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