Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation
- To determine the incidence of 1-year disease-free survival in patients with juvenile
myelomonocytic leukemia and who is undergoing a repeat stem cell transplantation.
- To evaluate the incidence of regimen-related toxicity.
- To evaluate the incidence of acute and chronic graft-versus-host-disease.
- To evaluate the incidence of relapse.
- Preparative cytoreductive therapy: Patients receive high-dose cytarabine IV over 2
hours on days -9 to -4 and mitoxantrone hydrochloride IV over 30 minutes on days -9 to
- Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day
0. Patients undergoing umbilical cord blood transplantation receive methylprednisolone
(as graft failure prophylaxis) IV twice daily on days 5 to 19 followed by a taper every
other day thereafter until day 25.
- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2
hours every 8-12 hours or orally twice daily beginning on day -3 and continuing until
day 50, followed by a taper to day 90, in the absence of GVHD. Patients undergoing
nongenotypically identical bone marrow transplantation also receive methotrexate IV on
day 1 beginning 24 hours after completion of stem cell infusion and on days 3, 6, and
- Post-transplantation isotretinoin therapy: Patients receive oral isotretinoin once
daily beginning on day 60 and continuing until 1 year after HSCT.
Patients undergo bone marrow sample collection on day 21, day 60, day 100, at 6 months, and
at 1 year for chimerism studies. Patients also undergo blood sample collection periodically
to monitor peripheral blood counts for immune reconstitution.
After completion of study treatment, patients are followed on day 21, day 100, at 6 months,
and at 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients who were free of disease and alive at 1 year.
Margaret L. MacMillan, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|