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A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS


Phase 3
N/A
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS


OBJECTIVES: I. Compare the efficacy of T-cell-depleted vs unmodified allogeneic marrow
rescue with regard to disease-free survival, post-transplantation leukemic relapse rate,
incidence and severity of graft-versus-host disease, quality of engraftment and
hematopoietic reconstitution, and immunoreconstitution following transplantation in patients
with acute leukemia in first or second remission.

OUTLINE: This is a randomized study. Patients are stratified according to disease (acute
lymphocytic leukemia (ALL) vs acute myeloid leukemia (AML), and age (20 and under vs over
20). Patients are randomized to one of two treatment arms. Patients under age 5 are
nonrandomly assigned to Arm I and those over age 55 are nonrandomly assigned to Arm II. Arm
I: Patients receive total body radiotherapy on days -7 through -4 followed by
cyclophosphamide IV on days -3 and -2. Patients undergo allogeneic bone marrow
transplantation (ABMT) IV over 2-4 hours on day 0. Patients also receive standard graft vs
host disease prophylaxis with cyclosporine and methotrexate. Arm II: Patients receive total
body radiotherapy on days -9 through -6, thiotepa IV on days -5 and -4, and cyclophosphamide
as in Arm I. Patients undergo T-cell depleted ABMT IV over 15 minutes on day 0. Patients
over age 15 receiving bone marrow from female donors over age 30 or from male donors of any
age also receive graft rejection prophylaxis consisting of antithymocyte globulin IV over
6-8 hours on days -5 and -4 and oral methylprednisolone twice daily on days -5 and -4.
Beginning 2 months following transplantation, adult patients with AML and a prior history of
CNS disease, all adult patients with ALL, and all pediatric patients (ALL and ANLL) receive
CNS leukemia prophylaxis with cytarabine intrathecally with the diagnostic lumbar puncture
and then monthly for 5 months (1 year in patients with a prior history of CNS leukemia).

PROJECTED ACCRUAL: A total of 128 patients will be randomized. At an anticipated accrual
rate of 35 patients/year, accrual is expected to be completed in 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Acute leukemias in the following categories: Histologically
documented ANLL in first remission (CR1) or second remission (CR2) Pediatric ANLL patients
in CR1 eligible provided they are not enrolled on protocol CCG-2891 ALL in CR1 presenting
with at least 1 of the following high-risk features: WBC at presentation greater than
50,000/mm3 (200,000/mm3 in pediatric patients) Hypoploidy as measured by flow cytometry
Pseudodiploidy with translocations t(9;22), t(4;11), and t(8;14) CR not achieved until
after 4 weeks of induction therapy ALL in CR2 that has relapsed in the bone marrow
following a first remission regardless of time of relapse Acute biphenotypic leukemia
(mixed myeloid and lymphoid lineage at presentation) in CR1 or CR2, i.e., patients
classified as lymphoblastic or myeloblastic based on FAB morphology and histochemistry
features Adult acute undifferentiated leukemia (no evidence of lymphoid or myeloid
differentiation) and in CR1 or CR2 Patients in this category are analyzed separately CR
defined as no evidence of leukemia at time of transplantation as documented by
normocellular bone marrow aspirate containing no more than 5% blasts no more than 2 weeks
prior to cytoreduction Normal diagnostic LP or Ommaya reservoir tap required no more than
2 weeks prior to start of cytoreduction in all ALL patients and in ANLL patients at risk
for CNS disease No extramedullary disease at time of transplantation HLA-identical,
MLC-compatible related donor required Donor must be healthy and willing to undergo general
anesthesia and donation procedure For T-cell depletion, donor should be able to have a
volume of 15 ml/kg patient body weight harvested safely

PATIENT CHARACTERISTICS: Age: Any age (5 to 55 to be eligible for randomization)
Performance status: Karnofsky (or Lansky) 70-100% Life expectancy: Greater than 8 weeks
Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dl SGOT no
greater than 3 times upper limit of normal (ULN) (both parameters stable for at least 4
weeks prior to transplantation) Renal: Creatinine less than 2 times ULN and stable for at
least 4 weeks prior to transplantation OR Creatinine clearance at least 70 mL/min
Cardiovascular: Fractional shortening greater than 28% on echocardiogram (23-28% if FS
increases as a response to stress on supine bicycle ergometer) LVEF at least 50% on
echocardiogram or MUGA Other: In good clinical condition at time of transplantation with
no medical problems that would significantly increase the risk of the procedure No
infection at time of transplantation Not pregnant or nursing

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Farid Boulad, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

93-045

NCT ID:

NCT00002534

Start Date:

May 1993

Completion Date:

April 2003

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult 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
  • acute undifferentiated leukemia
  • Leukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021