Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
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ClinicalTrials.gov Identifier: NCT00004255 |
Recruitment Status :
Completed
First Posted : May 9, 2003
Last Update Posted : July 10, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Versus Host Disease Leukemia Myelodysplastic Syndromes | Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Radiation: radiation therapy | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia |
Study Start Date : | March 2000 |
Actual Study Completion Date : | May 2003 |


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Ages Eligible for Study: | 12 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004255
United States, California | |
University of California San Diego Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
United States, Colorado | |
Presbyterian-St Luke's Medical Center | |
Denver, Colorado, United States, 80218 | |
United States, District of Columbia | |
Lombardi Cancer Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Shands Hospital and Clinics, University of Florida | |
Gainesville, Florida, United States, 32610-100277 | |
United States, Indiana | |
Indiana Blood and Marrow Transplantation | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kentucky | |
James Graham Brown Cancer Center | |
Louisville, Kentucky, United States, 40202 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, New York | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14642 | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73190 | |
United States, Oregon | |
Oregon Cancer Center | |
Portland, Oregon, United States, 97201-3098 | |
United States, Pennsylvania | |
Hahnemann University Hospital | |
Philadelphia, Pennsylvania, United States, 19102-1192 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
South Texas Cancer Institute | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0037 |
Study Chair: | James N. Lowder, MD | Chimeric Therapies |
ClinicalTrials.gov Identifier: | NCT00004255 |
Other Study ID Numbers: |
CHIMERIC-HM01 CDR0000067502 ( Registry Identifier: PDQ (Physician Data Query) ) WSU-10-02-99-M01-FB |
First Posted: | May 9, 2003 Key Record Dates |
Last Update Posted: | July 10, 2013 |
Last Verified: | February 2002 |
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 |
Leukemia Preleukemia Myelodysplastic Syndromes Graft vs Host Disease Syndrome Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Immune System Diseases Methylprednisolone Cyclophosphamide |
Fludarabine Fludarabine phosphate Tacrolimus Antilymphocyte Serum Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |