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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.
Last refreshed on: 17 October 2012
Main ID:  NCT00003187
Date of registration: 02/05/2000
Primary sponsor: Virginia Commonwealth University
Public title: Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
Scientific title: The Unrelated Donor Marrow Transplantation Trial
Date of first enrolment: May 1995
Target sample size: 19
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   Lee Ann Jensen, PhD
Affiliation:  National Heart, Lung, and Blood Institute (NHLBI)
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Pathologically confirmed acute myeloid leukemia Not in first
complete remission with translocations t(8;21) unless failed first line induction therapy
Not in first complete remission with translocations t(15;17) or 16q abnormality unless:
Failed first line induction therapy OR Molecular evidence of disease Pathologically
confirmed acute lymphoblastic lymphoma (ALL) Not in first complete remission OR High risk
ALL in first complete remission defined as: Hypodiploidy OR Pseudodiploidy with
translocations t(9,22), t(4;11), or t(8;14) OR Elevated WBC at presentation Greater than
100,000/mm3 if 6-12 months old Greater than 50,000/mm3 if 10-20 years old Greater than
20,000/mm3 if 21 or over OR Failed to achieve complete remission after 4 weeks of
induction therapy Pathologically confirmed chronic myelogenous leukemia (CML) not in blast
crisis Pathologically confirmed undifferentiated leukemia or biphenotypic leukemia
Pathologically confirmed juvenile CML with or without either 7q- or infantile monosomy 7
Leukocytosis with absolute monocytosis greater than 450 microliters AND Immature myeloid
cells in peripheral blood circulation Less than 25% marrow blasts Myelodysplastic
syndromes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts (RAEB)
RAEB in transformation Chronic myelomonocytic leukemia Pathologically confirmed stage IV
lymphoblastic lymphoma No active CNS or skin leukemic involvement No consenting suitably
HLA-matched related donor available Consenting unrelated donor available

PATIENT CHARACTERISTICS: Age: 55 and under Performance status: Karnofsky 70-100% OR Lansky
60-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Renal:
Creatinine within normal range OR Creatinine clearance greater than 60 mL/min
Cardiovascular: Asymptomatic OR Left ventricular ejection fraction at rest greater than
40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% Other: Not
pregnant or lactating HIV negative No uncontrolled viral, bacterial, or fungal infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior autologous or allogeneic bone marrow
transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified
Radiotherapy: No concurrent mediastinal radiation No prior radiation therapy that would
preclude total body irradiation Surgery: Not specified

Age minimum: N/A
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Myelodysplastic Syndromes
Biological: filgrastim
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Radiation: radiation therapy
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
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