Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00003187
• Date of registration: 02/05/2000
• Prospective Registration: No
• 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
• URL: http://clinicaltrials.gov/show/NCT00003187
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• 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

Lymphoma

Leukemia

Myelodysplastic Syndromes

Intervention(s)

Biological: filgrastim

Drug: cyclosporine

Drug: cytarabine

Procedure: allogeneic bone marrow transplantation

Drug: cyclophosphamide

Radiation: radiation therapy

Procedure: in vitro-treated bone marrow transplantation

Drug: methotrexate

Drug: methylprednisolone

Secondary ID(s)

MCV-CCHR-9504-2X

CDR0000066016

NCI-G98-1388

DUMC-75951

P30CA016059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)