Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

NCT00093587 | Unknown

• 3 other identifiers: CDR0000389241UCLA-0402009-01GENZ-SMC-101-1026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening. PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia.

Conditions

Graft Versus Host Disease; Leukemia

Keywords

graft versus host disease; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); secondary acute myeloid leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission

Interventions

anti-thymocyte globulin BIOLOGICAL

busulfan DRUG

cyclophosphamide DRUG

cyclosporine DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia * In first complete remission or second complete remission * Secondary AML allowed * HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits) * Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide * All patients from a center should receive the same conditioning regimen throughout the study * No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen * No uncontrolled CNS disease PATIENT CHARACTERISTICS: Age * 18 to 55 Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 2 mg/dL * ALT and/or AST ≤ 3 times normal Renal * Creatinine \< 2.0 mg/dL OR * Creatinine clearance \> 50 mL/min Cardiovascular * Ejection fraction \> 40% * No severe cardiac disease Other * Negative pregnancy test * Fertile patients must use effective contraception * No known contraindication to administration of rabbit anti-thymocyte globulin * No current drug or alcohol abuse * No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis * No IV immunoglobulin prior to engraftment * No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion) Chemotherapy * See Disease Characteristics * No prior or concurrent methotrexate for graft-vs-host disease prophylaxis Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior experimental agents * No other concurrent investigational agents * Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1678, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia; Congenital Abnormalities

Interventions

Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Gary J. Schiller, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: August 1, 2004
• Last Updated: November 6, 2013

Record last verified: 2006-01

Locations

US (1)