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CompletedNCT00004255Updated Jul 10, 2013

Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation

A Phase 2/3 interventional study of anti-thymocyte globulin and filgrastim in Graft Versus Host Disease, Leukemia and Myelodysplastic Syndromes, sponsored by Chimeric Therapies. Completed at 15 sites in United States. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-07-10.

Sponsored by Chimeric Therapies · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Allocation
Randomized
Ages
12 Years to 50 Years
Sex
All
01

Study summary

RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of processed (cell depleted) vs unprocessed (conventional) unrelated bone marrow transplantation in reducing grade III/IV acute graft vs host disease (GVHD) in patients with acute or chronic leukemia or myelodysplastic syndromes.
  • Compare the safety of these regimens in these patients.
  • Compare the disease-free survival rate at 100 days and at 6 months in patients treated with these regimens.
  • Compare the time to engraftment and percent engraftment in patients treated with these regimens.
  • Compare the reduction rate of grade II or greater acute and chronic GVHD in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes (yes vs no). Patients are randomized to one of two bone marrow transplantation arms.

All patients receive a conditioning regimen comprising fludarabine IV on day -6, cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim (G-CSF) is administered subcutaneously from day 0 until blood counts recover.

  • Arm I: Patients receive allogeneic bone marrow that has been processed to produce a mononuclear cell preparation.
  • Arm II: Patients receive unprocessed allogeneic bone marrow. Patients are followed weekly for 100 days and then at 6 months.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.

02

Conditions studied

  • Graft Versus Host Disease
  • Leukemia
  • Myelodysplastic Syndromes

Keywords

  • recurrent childhood acute lymphoblastic leukemia
  • 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 myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • childhood myelodysplastic syndromes
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

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Lead sponsor

This is the only study on the registry with Chimeric Therapies as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission
    • AML in first complete remission with one of the following adverse features:

      • Antecedent hematologic disorder such as myelodysplasia
      • AML resulting from prior chemotherapy or radiotherapy
      • More than 1 course of induction chemotherapy to achieve remission or adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11; abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3)
    • ALL in first complete remission with poor risk cytogenetics such as

      • Philadelphia chromosome 9:22, 8:14, or 4:11 OR
      • WBC greater than 100,000/mm3 OR
      • Time to achieve complete remission more than 4 weeks
    • Chronic myelogenous leukemia in chronic or accelerated phase
    • Myelodysplastic syndromes

      • Refractory anemia with excess blasts (RAEB) OR
      • RAEB in transformation
  • Unrelated bone marrow donor available

    • If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years
    • If matched at 5 of 6 loci, patient must be 12 to 35 years
  • No matched sibling donor available
  • No uncontrolled CNS leukemia

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • 12 to 50

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin less than 2.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • LVEF greater than 50% without medication

Pulmonary:

  • DLCO and FVC at least 50% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious medical illness
  • No uncontrolled diabetes mellitus
  • No uncontrolled and/or active infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunotherapy and recovered
  • At least 1 year since prior autologous transplantation
  • No prior allogeneic transplantation

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered

Endocrine therapy:

  • At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy at doses that would preclude study

Surgery:

  • Not specified
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)

Interventions

  • Biologicalanti-thymocyte globulin
  • Biologicalfilgrastim
  • Drugcyclophosphamide
  • Drugfludarabine phosphate
  • Drugmethylprednisolone
  • Drugtacrolimus
  • Procedureallogeneic bone marrow transplantation
  • Procedurein vitro-treated bone marrow transplantation
  • Radiationradiation therapy
06

Study locations

15 sites
  • University of California San Diego Cancer Center
    La Jolla, California 92093-0658, United States
  • Presbyterian-St Luke's Medical Center
    Denver, Colorado 80218, United States
  • Lombardi Cancer Center
    Washington, District of Columbia 20007, United States
  • Shands Hospital and Clinics, University of Florida
    Gainesville, Florida 32610-100277, United States
  • Indiana Blood and Marrow Transplantation
    Indianapolis, Indiana 46202, United States
  • James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • University of Rochester Cancer Center
    Rochester, New York 14642, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73190, United States
  • Oregon Cancer Center
    Portland, Oregon 97201-3098, United States
  • Hahnemann University Hospital
    Philadelphia, Pennsylvania 19102-1192, United States
  • University of Texas - MD Anderson Cancer Center
    Houston, Texas 77030-4009, United States
  • South Texas Cancer Institute
    San Antonio, Texas 78229, United States
  • Massey Cancer Center
    Richmond, Virginia 23298-0037, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004255
Lead sponsor
Chimeric Therapies
First posted
May 9, 2003
Start date
Mar 2000
Completion
May 2003
Last update
Jul 10, 2013

Study contacts

James N. Lowder, MD
study chair · Chimeric Therapies
View the source record on ClinicalTrials.gov ↗

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