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| Sponsored by: |
Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00167219 |
Purpose
The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).
| Condition | Intervention | Phase |
|---|---|---|
|
Juvenile Myelomonocytic Leukemia |
Procedure: Stem Cell Transplant |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 1999 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):
Adequate major organ function including:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret MacMillan, M.D. | 612-626-2778 | macmi002@umn.edu |
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Margaret MacMillan, MD 612-626-2778 macmi002@umn.edu | |
| Principal Investigator: | Margaret MacMillan, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Masonic Cancer Center, University of Minnesota ( MacMillan, Margaret L., MD ) |
| Study ID Numbers: | 9911M24961, MT1999-20, 1999LS073 |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00167219 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Stem cell transplant long term survival retinoic acid |
|
Melphalan Chronic Myelomonocytic Leukemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia Leukemia, Myelomonocytic, Juvenile Leukemia, Myeloid |
Cyclophosphamide Leukemia, Myelomonocytic, Acute Leukemia Busulfan Tretinoin Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Myelodysplastic Myeloproliferative Disease |
|
Leukemia, Myelomonocytic, Acute Leukemia Neoplasms Neoplasms by Histologic Type Hematologic Diseases |
Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid Leukemia, Myelomonocytic, Juvenile Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases |