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NCT01824693 · ClinicalTrials.gov registry record · Phase 2
Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia
A Phase 2 study of Juvenile Myelomonocytic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT01824693: Completed Phase 2 study of Juvenile Myelomonocytic Leukemia, sponsored by Children's Oncology Group.
NCT01824693 is a Phase 2 study of Juvenile Myelomonocytic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 30 participants, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01824693, a Phase 2 study of Juvenile Myelomonocytic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy before a donor hematopoietic transplant helps stop the growth of cancer cells. It may also 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. It is not yet known whether giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before a donor stem cell transplant is more effective in treating juvenile myelomonocytic leukemia.
Primary Outcome
Probability of Event-free Survival (EFS) for Patients after 18 months. An event is either treatment related mortality (TRM), primary or secondary graft failure, or relapse/non-response (as defined in protocol section 10). Time to event is time from transplant with patients who die between the start of the conditioning regimen and transplant given a time to event of zero.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Mattel Children's Hospital UCLA - Los Angeles
- Children's Hospital of Orange County - Orange
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Johns Hopkins All Children's Hospital - St. Petersburg
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-06-24 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 2 |
What the finished NCT01824693 record still lists
NCT01824693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Juvenile Myelomonocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01824693 names 20 study sites across 14 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01824693 about?
NCT01824693 is a clinical study titled "Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia". This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy before a donor hematopoietic...
What is the current status of trial NCT01824693?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2013-06-24. Estimated completion is 2017-12-31.
What conditions does trial NCT01824693 study?
This clinical trial studies the following conditions: Juvenile Myelomonocytic Leukemia.
What interventions are being tested in trial NCT01824693?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01824693?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01824693 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01824693's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Juvenile Myelomonocytic 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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