Bone Marrow Transplantation in Treating Patients With Leukemia

NCT00006451 | Withdrawn Phase 3 DMC

• 2 other identifiers: 1996LS142UMN-MT-9506
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia.

Conditions

Graft Versus Host Disease; Leukemia; Lymphoma

Keywords

recurrent childhood acute lymphoblastic leukemia; stage IV childhood lymphoblastic lymphoma; 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 lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission; acute undifferentiated leukemia; stage IV adult lymphoblastic lymphoma; graft versus host disease

Interventions

anti-thymocyte globulin DRUG

cyclophosphamide DRUG

cyclosporine DRUG

methotrexate DRUG

methylprednisolone DRUG

allogeneic bone marrow transplantation PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

radiation therapy PROCEDURE

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Acute myelocytic leukemia with or without history of myelodysplastic syndrome Not in first complete remission (i.e., greater than 5% blasts in marrow) with t(8;21), t(15;17), or 16q abnormality unless failure on first-line induction therapy Acute lymphocytic leukemia (ALL) in one of the following categories: In second or third complete remission (CR) High-risk ALL in first CR, with high risk defined as: Hypodiploidy OR pseudodiploidy with t(9;22), t(4;11), or t(8;14) Failure to achieve CR after 4 weeks of induction therapy Elevated WBC at presentation, i.e.: Greater than 100,000 in patients aged 6 to 12 months Greater than 200,000 in patients aged 1 to 20 years Greater than 20,000 in patients aged 21 to 44 years Chronic myelogenous leukemia not in blast crisis (i.e., no greater than 30% promyelocytes plus blasts in bone marrow) Stage IV lymphoblastic lymphoma Undifferentiated or biphenotypic leukemia Unrelated donor available Patients aged 35 and younger: HLA-A, and -B serologic identity and HLA-DRB1 identity by high-resolution DNA typing OR Single HLA-A or -B serologic mismatch with DRB1 identity by high-resolution DNA typing OR HLA-A and -B serologic identity with single DRB1 mismatch by high- or low- resolution DNA typing Patients aged 36 to 44: HLA-A and -B serologic identity and HLA-DRB1 identity by high-resolution DNA typing The following exclude: Relapse 12 months after discontinuing therapy in patients aged 1 to 10 years who are in second remission Active central nervous system or leukemic skin involvement Requirement for additional mediastinal irradiation PATIENT CHARACTERISTICS: Age: Under 46 Performance status: Karnofsky 70-100% Lansky 50-100% Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL AST less than 3 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic OR Resting LVEF greater than 40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% of predicted (corrected for hemoglobin) Other: HIV negative No uncontrolled viral, bacterial, or fungal infection Not pregnant or nursing PRIOR CONCURRENT THERAPY: No prior bone marrow transplantation No prior radiotherapy that precludes total body irradiation

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Leukemia, Biphenotypic, Acute

Interventions

Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Methotrexate; Methylprednisolone; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Therapeutics

Study Officials

• John E. Wagner, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: June 9, 2004
• Study Start: April 1, 1996
• Primary Completion: November 1, 2000
• Study Completion: November 1, 2000
• Last Updated: January 3, 2020

Record last verified: 2017-11

Locations

US (1)