drugset / Trial / NCT01824693

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia

NCT01824693 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-06-24
Primary completion
2017-12-31
Completion
2017-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Fludarabine Small molecule — Intravenous
Subject Melphalan Small molecule — Intravenous
Background Busulfan Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous