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

NCT00004255 | Completed Phase 2

• 3 other identifiers: CHIMERIC-HM01CDR0000067502WSU-10-02-99-M01-FB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Interventions

anti-thymocyte globulin BIOLOGICAL

filgrastim BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

methylprednisolone DRUG

tacrolimus DRUG

allogeneic bone marrow transplantation PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Chimeric Therapies: lead

Study Sites (15)

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Presbyterian-St Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, 46202, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon Cancer Center

Portland, Oregon, 97201-3098, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

South Texas Cancer Institute

San Antonio, Texas, 78229, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Anemia, Refractory, with Excess of Blasts

Interventions

Antilymphocyte Serum; Filgrastim; Cyclophosphamide; fludarabine phosphate; Methylprednisolone; Tacrolimus; Radiotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones; Therapeutics

Study Officials

• James N. Lowder, MD

  Chimeric Therapies

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: May 9, 2003
• Study Start: March 1, 2000
• Study Completion: May 1, 2003
• Last Updated: July 10, 2013

Record last verified: 2002-02

Locations

US (15)