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Phase I/II Study of Cytoreduction Therapy Comprising High-Dose Cytarabine and Mitoxantrone Hydrochloride in Patients With Juvenile Myelomonocytic Leukemia Undergoing a Second Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Residual Disease
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
High-Dose Cytarabine and Mitoxantrone in Treating Patients With Juvenile Myelomonocytic Leukemia Undergoing a Second Donor Stem Cell Transplant
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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Juvenile
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NCI
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UMN-1999LS032 UMN-1999LS032, UMN-MT1999-08, NCT00609739
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Objectives Primary - 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.
Secondary - 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.
Entry Criteria Disease Characteristics:
- Diagnosis of juvenile myelomonocytic leukemia (JMML)
- Relapsed or residual disease after initial allogeneic hematopoietic stem cell transplantation (HSCT)
- Patients should be ≥ 6 months from first HSCT, if clinically stable
- In patients with rapidly progressive JMML, second HSCT may be performed earlier
- Available donor should be the same type as used in the initial HSCT or a greater HLA-disparate donor to enhance possibility of graft-versus-leukemia
- Stem cell source may be allogeneic bone marrow or umbilical cord blood
- Cord blood units selected for transplantation must contain ≥ 1 x 107 nucleated cells/kg patient body weight
Prior/Concurrent Therapy:
- See Disease Characteristics
Patient Characteristics:
- Karnofsky performance status (PS) 70-100% or Lansky PS 50-100%
- Ejection fraction ≥ 45%
- FEV1 > 50%
- DLCO > 50%
- Creatinine clearance ≥ 40 mL/min
- No clinical evidence of hepatic failure (e.g., coagulopathy or ascites)
- No active uncontrolled infection within 1 week of HSCT
Expected Enrollment 10Outcomes Primary Outcome(s)1-year disease-free survival
Secondary Outcome(s)Incidence of regimen-related toxicity Incidence of acute and chronic graft-versus-host-disease Incidence of relapse
Outline - 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 -7.
- 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 11.
- Post-transplantation isotretinoin therapy: Patients receive oral isotretinoin once daily beginning on day 50 and continuing until 1 year after HSCT.
Patients undergo bone marrow sample collection on day 21, 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.
Trial Contact Information
Trial Lead Organizations Masonic Cancer Center at University of Minnesota | | | Margaret MacMillan, MD, Principal investigator | | | | Trial Sites
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U.S.A. |
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Minnesota |
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Minneapolis |
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| | | | | | | | Masonic Cancer Center at University of Minnesota |
| | Clinical Trials Office - Masonic Cancer Center at University of Minnesota | |
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Registry Information | | Official Title | | Cytosine Arabinoside and Mitoxantrone for Patients with Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation | | Trial Start Date | | 1999-06-17 | | Trial Completion Date | | 2013-01-07 (estimated) | | Registered in ClinicalTrials.gov | | NCT00609739 | | Date Submitted to PDQ | | 2008-01-22 | | Information Last Verified | | 2008-09-12 | | NCI Grant/Contract Number | | CA77598 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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