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NCT01041508 · ClinicalTrials.gov registry record · Phase 1
Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01041508: Completed Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01041508 is a Phase 1 study that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041508, a Phase 1 study, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Stem cell transplant is an important therapeutic option for pediatric patients with relapsed or refractory leukemia. Although, full myeloablative transplants are widely used for patients with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific settings. These settings include 1) patients with pre-existing health issues and organ toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem cell transplant; and 3) leukemia patients with advanced disease who have been heavily pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of significant antileukemic activity in addition to its possible immuno-suppressive properties. In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in combination with total body irradiation that can achieve durable donor engraftment without causing excessive toxicity.
Primary Outcome
The primary objective of the study is to determine the maximum feasible dose (MFD) of Clofarabine that can be given in combination with 2Gy total body irradiation as a non-myeloablative preparative regimen for allogeneic stem cell transplantation in pediatric patients with relapsed leukemia. The MFD is defined as the highest clofarabine dose associated with both an acceptably low toxicity and low non-engraftment (NE) rate. NE is defined as \< 5% donor T cells at any time point during serial moni
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Cyclosporine
- RADIATION Total Body Irradiation
- DRUG Clofarabine
- OTHER Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-01-29 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01041508 record still lists
NCT01041508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT01041508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041508 about?
NCT01041508 is a clinical study titled "Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.". Stem cell transplant is an important therapeutic option for pediatric patients with relapsed or refractory leukemia. Although, full myeloablative transplants are widely used for patients with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific settings. These settin...
What is the current status of trial NCT01041508?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-01-29. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01041508?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Cyclosporine (DRUG), Total Body Irradiation (RADIATION), Clofarabine (DRUG), Stem Cell Transplantation (OTHER).
Who is sponsoring clinical trial NCT01041508?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041508's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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