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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00167219 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
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Scientific title:
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Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia |
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Date of first enrolment:
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December 1999 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00167219 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Margaret MacMillan, MD |
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Address:
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Telephone:
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612-626-2778 |
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Email:
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macmi002@umn.edu |
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Affiliation:
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Name:
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Patricia Kleinke, RN |
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Address:
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Telephone:
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612-273-0857 |
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Email:
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pkleink1@fairview.org |
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Affiliation:
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Name:
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Margaret MacMillan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Masonic Cancer Center, University of Minnesota |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- Active uncontrolled infection within one week of HCT.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Juvenile Myelomonocytic Leukemia
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Intervention(s)
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Procedure: Stem Cell Transplant
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Primary Outcome(s)
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Determine probability of long-term disease free survival in JMML
[Time Frame: at 1 year after transplant]
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Secondary Outcome(s)
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Secondary outcome measures are the incidence of neutrophil engraftment, graft-versus-host disease (GVHD), regimen-related toxicity, and relapse.
[Time Frame: at 1 year after transplant]
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Secondary ID(s)
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1999LS073
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9911M24961
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MT1999-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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