Status:
COMPLETED
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Juvenile Myelomonocytic Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief Summary
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 b...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):
- Leukocytosis (\> 13,000) with absolute monocytosis (\> 1,000)
- The presence of immature myeloid cells in the peripheral blood
- Less than 30% marrow blasts
- Absence of t(9:22) or BCR-ABL transcript
- Adequate major organ function including:
- Cardiac: ejection fraction \> 45%
- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- Karnofsky performance status \> 70% or Lansky score \> 50%
- Creatinine must be \< 2 x normal for age
- Written informed consent.
Exclusion
- Active uncontrolled infection within one week of HCT.
Key Trial Info
Start Date :
November 18 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00167219
Start Date
November 18 1999
End Date
August 9 2023
Last Update
November 7 2023
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455