Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
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|ClinicalTrials.gov Identifier: NCT00167219|
Recruitment Status : Recruiting
First Posted : September 14, 2005
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Myelomonocytic Leukemia||Biological: Stem Cell Transplant Drug: Preparative Regimen||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia|
|Actual Study Start Date :||November 18, 1999|
|Estimated Primary Completion Date :||July 28, 2022|
|Estimated Study Completion Date :||July 28, 2022|
Patients receiving study regimen.
Biological: Stem Cell Transplant
Transplantation on Day 0.
Other Name: Bone marrow transplantation
Drug: Preparative Regimen
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167219
|Contact: Lisa Burke, RN||612-273-8482||lburke3@Fairview.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Lisa Burke 612-273-8482 lburke3@Fairview.org|
|Principal Investigator:||Margaret MacMillan, MD||Masonic Cancer Center, University of Minnesota|