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The Unrelated Donor Marrow Transplantation Trial

Phase 2/Phase 3
55 Years
Not Enrolling
Leukemia, Lymphoma, Myelodysplastic Syndromes

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Trial Information

The Unrelated Donor Marrow Transplantation Trial

OBJECTIVES: I. Compare the disease free survival of patients with leukemia, myelodysplasia,
or lymphoblastic lymphoma after treatment with conventional (non-T cell depleted) or T cell
depleted unrelated donor bone marrow transplantation. II. Compare the incidence of primary
and secondary graft failure, acute and chronic graft-vs-host disease, complications
(infection, veno-occlusive disease, interstitial pneumonitis), and relapse in these patients
after these treatments. III. Compare the incidence of other malignancies,
lymphoproliferative disorders, and post-transplant myelodysplasia in these patients after
these treatments.

OUTLINE: This is a randomized, multicenter study. Patients will be stratified according to
institution. Patients are assigned to one of two treatment arms, one with conventional bone
marrow transplantation (arm I) and one with T cell depletion of the bone marrow (arm II).
Arm I: Patients receive cyclophosphamide on days -6 and -5. Total body irradiation (TBI) is
administered on days -4 to 0, although this order may be reversed. Males with ALL receive a
testicular boost of radiation therapy. Bone marrow is infused on day 0. Patients receive
cyclosporine beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Arm II: T cell
depletion is conducted by 2 different methods, according to the institution, and treatment
varies depending on the method used. Method I is by T10B9 depletion and Method II is by
counterflow elutriation depletion. Method I: Depending on the institution, some patients
receive TBI on days -9 to -7 (before chemotherapy) (Course I) and some receive TBI on days
-3 to -1 (after chemotherapy) (Course II). Course I also includes cytarabine IV on days -5
to -3, cyclophosphamide IV on days -2 and -1, and methylprednisolone IV on days -2 to 0 and
5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day -1. Course
II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5.
Methylprednisolone IV is administered on days -2 to 0 and 5-18. Bone marrow infusion is
administered on day 0. Cyclosporine begins on day 0. Method II: Preparative therapy varies
according to the disease category. Acute lymphoblastic leukemia: Patients undergo TBI on
days -7 to -4. Males receive testicular boost on day -7, and all receive electron boost to
anterior and posterior chest wall on days -5 and -4. Cyclophosphamide IV is administered on
days -3 and -2. Bone marrow infusion is administered on day 0. Acute nonlymphocytic
leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome: Patients receive
cyclophosphamide IV on days -7 and -6, followed by TBI on days -4 to -1. Bone marrow
infusion is administered on day 0. Patients receive methylprednisolone IV every 12 hr on
days -2,-1, and 5-19. Cyclosporine is administered from day -3 to day 180. All patients on
both arms receive filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning on day
7 post-transplant. Patients are followed weekly for the first 14 weeks, at day 100, every 6
months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 4 years.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Lee Ann Jensen, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)


United States: Federal Government

Study ID:




Start Date:

May 1995

Completion Date:

February 2005

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • acute undifferentiated leukemia
  • stage IV adult lymphoblastic lymphoma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin



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