Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 18 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041508
The ClinicalTrials.gov registry entry for NCT01041508 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT01041508 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.