Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia

NCT00027547 | Completed Phase 1

• 4 other identifiers: 1586.00FHCRC-1586.00NCI-H01-0080CDR0000069042
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor white blood cells may prevent this from happening. PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

cyclosporine DRUG

cytarabine DRUG

fludarabine phosphate DRUG

methotrexate DRUG

mycophenolate mofetil DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * Adult patients must meet 1 of the following criteria: * Age 50 to 75 with high-risk ALL in complete remission (CR) (less than 5% blasts by morphology on bone marrow aspirate and absence of peripheral blasts) or ALL in second CR (CR2) or greater * Age 18 to 50 with high-risk ALL in first CR (CR1) and either ineligible for conventional allogeneic transplantation (based on general medical condition) or refused conventional transplantation * High-risk adult ALL in CR1 includes patients meeting 1 or more of the following criteria: * Age 30 and over * Non-T-cell phenotype * Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7 * Failure to achieve CR after 4 weeks of induction chemotherapy * Age 18 to 50 with ALL in CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition * Age 18 to 50 with high-risk ALL in CR2 or greater and refused conventional allogeneic transplantation * Pediatric patients must meet 1 of the following criteria: * Under age 18 with high-risk ALL in CR1 and ineligible for conventional allogeneic transplantation based on general medical condition * High-risk pediatric ALL in CR1 includes patients meeting 1 or more of the following criteria: * Cytogenetic abnormalities * t(9;22) with WBC at least 25,000/mm3 at diagnosis * t(4;11) in patients under age 1 or age 10 and over * Hypodiploidy (no more than 45 chromosomes) * Failure to achieve CR after 4 weeks of induction chemotherapy * Persistent peripheral blasts after 1 week of induction chemotherapy * Under age 18 with CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition * Age 12 and under allowed if approved by the principle investigator * No active CNS disease * Availability of a sibling donor (excluding an identical twin) * HLA genotypically identical for at least 1 haplotype * HLA-A, -B, -C, -DRB1, and -DQB1 genotypically or phenotypically identical PATIENT CHARACTERISTICS: Age: * See Disease Characteristics * 75 and under Performance status: * Karnofsky 50-100% (adults) * Lansky 40-100% (children) Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * No fulminant liver failure * No alcoholic hepatitis * No history of bleeding esophageal varices * No grade II or greater hepatic encephalopathy * No hepatic synthetic dysfunction evidenced by prolongation of PT with INR greater than 2.5 * No intractable ascites related to portal hypertension * No bacterial or fungal liver abscess * No chronic viral hepatitis with bilirubin greater than 5 mg/dL * No biliary obstruction with bilirubin greater than 5 mg/dL * No concurrent symptomatic biliary disease Renal: * Not specified Cardiovascular: * Cardiac ejection fraction at least 30% Pulmonary: * No requirement for supplementary continuous oxygen Other: * HIV negative * Not pregnant or nursing * Fertile patients must use effective contraception during and for 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent posttransplantation growth factors during mycophenolate mofetil administration Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Universitaet Leipzig

Leipzig, D-04103, Germany

Location

MeSH Terms

Conditions

Leukemia

Interventions

Cyclosporine; Cytarabine; fludarabine phosphate; Methotrexate; Mycophenolic Acid; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• George Georges, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Study Completion: July 1, 2004
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

DE (1); US (2)