Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma

NCT00003187 | Completed Phase 2

• 5 other identifiers: CDR0000066016P30CA016059MCV-CCHR-9504-2XDUMC-75951NCI-G98-1388
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia, myelodysplasia, or lymphoblastic lymphoma.

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndromes

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; relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; untreated adult acute lymphoblastic leukemia; untreated adult acute myeloid leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; untreated childhood acute lymphoblastic 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; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; acute undifferentiated leukemia; stage IV adult lymphoblastic lymphoma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; childhood myelodysplastic syndromes

Interventions

filgrastim BIOLOGICAL

cyclophosphamide DRUG

cyclosporine DRUG

cytarabine DRUG

methotrexate DRUG

methylprednisolone DRUG

allogeneic bone marrow transplantation PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Pathologically confirmed acute myeloid leukemia Not in first complete remission with translocations t(8;21) unless failed first line induction therapy Not in first complete remission with translocations t(15;17) or 16q abnormality unless: Failed first line induction therapy OR Molecular evidence of disease Pathologically confirmed acute lymphoblastic lymphoma (ALL) Not in first complete remission OR High risk ALL in first complete remission defined as: Hypodiploidy OR Pseudodiploidy with translocations t(9,22), t(4;11), or t(8;14) OR Elevated WBC at presentation Greater than 100,000/mm3 if 6-12 months old Greater than 50,000/mm3 if 10-20 years old Greater than 20,000/mm3 if 21 or over OR Failed to achieve complete remission after 4 weeks of induction therapy Pathologically confirmed chronic myelogenous leukemia (CML) not in blast crisis Pathologically confirmed undifferentiated leukemia or biphenotypic leukemia Pathologically confirmed juvenile CML with or without either 7q- or infantile monosomy 7 Leukocytosis with absolute monocytosis greater than 450 microliters AND Immature myeloid cells in peripheral blood circulation Less than 25% marrow blasts Myelodysplastic syndromes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Pathologically confirmed stage IV lymphoblastic lymphoma No active CNS or skin leukemic involvement No consenting suitably HLA-matched related donor available Consenting unrelated donor available PATIENT CHARACTERISTICS: Age: 55 and under Performance status: Karnofsky 70-100% OR Lansky 60-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Renal: Creatinine within normal range OR Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic OR Left ventricular ejection fraction at rest greater than 40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% Other: Not pregnant or lactating HIV negative No uncontrolled viral, bacterial, or fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy: No prior autologous or allogeneic bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No concurrent mediastinal radiation No prior radiation therapy that would preclude total body irradiation Surgery: Not specified

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University of South Carolina School of Medicine

Columbia, South Carolina, 29203, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Lehtoranta L, Hibberd AA, Yeung N, Laitila A, Maukonen J, Ouwehand AC. Characterization of vaginal fungal communities in healthy women and women with bacterial vaginosis (BV); a pilot study. Microb Pathog. 2021 Dec;161(Pt A):105055. doi: 10.1016/j.micpath.2021.105055. Epub 2021 Jun 17.

  PMID: 34146644 DERIVED

MeSH Terms

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Leukemia, Biphenotypic, Acute

Interventions

Filgrastim; Cyclophosphamide; Cyclosporine; Cytarabine; Methotrexate; Methylprednisolone; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; 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; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Therapeutics

Study Officials

• Lee Ann Jensen, PhD

  National Heart, Lung, and Blood Institute (NHLBI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: May 24, 2004
• Study Start: May 1, 1995
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: February 24, 2010

Record last verified: 2010-02

Locations

US (13)