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T-cell Depletion In Unrelated Donor Marrow Transplantation

Phase 3
45 Years
Not Enrolling
Graft Versus Host Disease, Leukemia, Lymphoma

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Trial Information

T-cell Depletion In Unrelated Donor Marrow Transplantation

OBJECTIVES: I. Compare unrelated donor bone marrow transplantation using T-cell-depleted
marrow versus unmodified marrow in adults and children with leukemia. II. Evaluate 2-year
leukemia-free survival, primary and secondary graft failure, graft-versus-host disease,
infection, and relapse in these patients. III. Assess the quality of life associated with
T-cell-depleted versus unmodified, unrelated donor transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center.
Patients receive myeloablative therapy according to diagnosis: those with acute lymphocytic
leukemia and lymphoblastic lymphoma are treated with total body irradiation (TBI), with a
testicular and chest wall boost as appropriate, followed by cyclophosphamide (CTX); patients
with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia
are treated with CTX followed by TBI. Patients are then randomly assigned to receive
non-T-cell-depleted, unrelated marrow versus T-cell-depleted, unrelated marrow. The modified
marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for
CD34 cells. Graft-versus-host disease (GVHD) prophylaxis with cyclosporine and methotrexate
is given to the unmodified marrow group. Patients who receive modified marrow are given
antithymocyte globulin (or methylprednisolone) for graft rejection prophylaxis before
transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after

Inclusion Criteria

DISEASE CHARACTERISTICS: Acute myelocytic leukemia with or without history of
myelodysplastic syndrome Not in first complete remission (i.e., greater than 5% blasts in
marrow) with t(8;21), t(15;17), or 16q abnormality unless failure on first-line induction
therapy Acute lymphocytic leukemia (ALL) in one of the following categories: In second or
third complete remission (CR) High-risk ALL in first CR, with high risk defined as:
Hypodiploidy OR pseudodiploidy with t(9;22), t(4;11), or t(8;14) Failure to achieve CR
after 4 weeks of induction therapy Elevated WBC at presentation, i.e.: Greater than
100,000 in patients aged 6 to 12 months Greater than 200,000 in patients aged 1 to 20
years Greater than 20,000 in patients aged 21 to 44 years Chronic myelogenous leukemia not
in blast crisis (i.e., no greater than 30% promyelocytes plus blasts in bone marrow) Stage
IV lymphoblastic lymphoma Undifferentiated or biphenotypic leukemia Unrelated donor
available Patients aged 35 and younger: HLA-A, and -B serologic identity and HLA-DRB1
identity by high-resolution DNA typing OR Single HLA-A or -B serologic mismatch with DRB1
identity by high-resolution DNA typing OR HLA-A and -B serologic identity with single DRB1
mismatch by high- or low- resolution DNA typing Patients aged 36 to 44: HLA-A and -B
serologic identity and HLA-DRB1 identity by high-resolution DNA typing The following
exclude: Relapse 12 months after discontinuing therapy in patients aged 1 to 10 years who
are in second remission Active central nervous system or leukemic skin involvement
Requirement for additional mediastinal irradiation

PATIENT CHARACTERISTICS: Age: Under 46 Performance status: Karnofsky 70-100% Lansky
50-100% Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL
AST less than 3 times normal Renal: Creatinine normal OR Creatinine clearance greater than
60 mL/min Cardiovascular: Asymptomatic OR Resting LVEF greater than 40% and improves with
exercise Pulmonary: Asymptomatic OR DLCO greater than 45% of predicted (corrected for
hemoglobin) Other: HIV negative No uncontrolled viral, bacterial, or fungal infection Not
pregnant or nursing

PRIOR CONCURRENT THERAPY: No prior bone marrow transplantation No prior radiotherapy that
precludes total body irradiation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

John E. Wagner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

April 1996

Completion Date:

November 2000

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • 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
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • acute undifferentiated leukemia
  • stage IV adult lymphoblastic lymphoma
  • graft versus host disease
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma



University of Minnesota Cancer Center Minneapolis, Minnesota  55455