Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
|Juvenile Myelomonocytic Leukemia||Biological: Stem Cell Transplant Drug: Preparative Regimen||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia|
- Determine probability of long-term disease free survival in JMML [ Time Frame: at 1 year after transplant ]
- Secondary outcome measures are the incidence of neutrophil engraftment, graft-versus-host disease (GVHD), regimen-related toxicity, and relapse. [ Time Frame: at 1 year after transplant ]
|Actual Study Start Date:||November 18, 1999|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Patients receiving study regimen.
Biological: Stem Cell Transplant
Transplantation on Day 0.
Other Name: Bone marrow transplantationDrug: Preparative Regimen
Prior to transplantation, subjects will receive BUSULFAN via the central venous line, six times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. As well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation.
On the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. These new cells will replace the subject's bone marrow.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167219
|Contact: Kim Nelson, RNemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Kim Nelson 612-273-2925 firstname.lastname@example.org|
|Principal Investigator:||Margaret MacMillan, MD||Masonic Cancer Center, University of Minnesota|