CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Busulfan +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01824693
NCT01824693Phase 2Completed

A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children With Juvenile Myelomonocytic Leukemia (JMML)

Children's Oncology Group·interventional·Posted Apr 5, 2013·Updated Dec 5, 2018

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, and 7 other interventions for Juvenile Myelomonocytic Leukemia. Completed, enrolled 30 participants across 50 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, United States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2013
Enrollment StartJun 24, 2013
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.2 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic HCT

Busulfandrug

Given IV

Cyclophosphamidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given IV or PO

Pharmacological Studyother

Correlative studies

Tacrolimusdrug

Given IV or PO