Status:
TERMINATED
Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rej...
Detailed Description
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. Secondar...
Eligibility Criteria
Inclusion
- Patients age 0-18 with juvenile myelomonocytic leukemia (JMML) who have relapsed or have residual disease after allogeneic HCT. Residual disease is defined as failure to eradicate original disease without prior documentation of remission. Relapse is defined as reappearance of i) leukocytosis with absolute monocytosis \>1 x 10\^8/L, ii) presence of immature myeloid cells in the peripheral circulation in two consecutive bone marrow specimens taken at least one month apart, or iii) presence of clonal cytogenetic abnormality. The diagnosis of relapse will be supported by the return of an abnormal cytogenetic marker (if present at diagnosis) or the presence of host cells by RFLP or other method.
- Patients should be at least 6 months from first hematopoietic cell transplant (HCT) if clinically stable. (If JMML is rapidly progressive, second HCT may be performed earlier).
- Adequate major organ function including:
- Cardiac: ejection fraction ≥45%
- Pulmonary: FEV \>50%, DLCO \>50%
- Renal: creatinine clearance ≥40 mL/min
- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- Karnofsky performance status ≥70% or Lansky score ≥50%
- Written informed consent.
Exclusion
- Active uncontrolled infection within one week of HCT.
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00609739
Start Date
June 1 1999
End Date
June 1 2010
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455