Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia

NCT00066417 | Terminated Phase 2

• 2 other identifiers: CDR0000315900NHLBI-03-H-0209
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia.

Conditions

Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic/Myeloproliferative Diseases

Keywords

essential thrombocythemia; polycythemia vera; blastic phase chronic myelogenous leukemia; secondary myelodysplastic syndromes; previously treated myelodysplastic syndromes; adult acute myeloid leukemia in remission; childhood acute myeloid leukemia in remission; de novo myelodysplastic syndromes; secondary acute myeloid leukemia; accelerated phase chronic myelogenous leukemia; childhood chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission; recurrent adult acute myeloid leukemia; relapsing chronic myelogenous leukemia; recurrent childhood acute myeloid leukemia; chronic idiopathic myelofibrosis; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (5)

• Incidence of graft failure 100 days post-transplant

• Incidence of acute and chronic graft-vs-host disease100 days post-transplant

• Transplant-related mortality 100 days post-transplant

• Disease-free survival 100 days post-transplant

• Overall survival 100 days post-transplant

Interventions

cyclophosphamide DRUG

cyclosporine DRUG

fludarabine phosphate DRUG

methylprednisolone DRUG

therapeutic allogeneic lymphocytes DRUG

thiotepa DRUG

allogeneic bone marrow transplantation PROCEDURE

biological therapy PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

bone marrow transplantation PROCEDURE

chemotherapy PROCEDURE

leukocyte therapy PROCEDURE

non-specific immune-modulator therapy PROCEDURE

peripheral blood lymphocyte therapy PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * High-risk myelodysplastic syndromes (MDS), meeting 1 of the following criteria: * Transformation to acute leukemia defined by at least 15% blasts * Secondary to prior treatment with chemotherapy and/or radiotherapy * Presence of complex cytogenetics (at least 3 karyotypic abnormalities) * Monosomy or deletion of chromosome 7 * Acute myeloid leukemia (AML), meeting 1 of the following criteria : * High-risk AML in first remission and meeting 1 of the following criteria: * At least 3 karyotypic abnormalities * Monosomy or deletion of chromosome 5 or 7 = 11q23 chromosomal abnormality * Prior diagnosis of MDS * Received prior radiotherapy or chemotherapy * In second or subsequent remission * Primary induction failure or partial remission * Untested or sensitive relapse * Chronic myelogenous leukemia, meeting 1 of the following criteria: * Blast crisis * Accelerated phase disease that has failed prior treatment with imatinib mesylate, defined as a failure to achieve hematologic response after 3 months of standard dose (600 mg/day) therapy or disease progression on therapy * Myeloproliferative disease * The following diagnoses are eligible: * Agnogenic myeloid metaplasia * Essential thrombocythemia * Polycythemia vera * Must have evidence of transformation to acute leukemia * Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria: * High-risk ALL in first remission defined by 1 of the following: * t(9;22) or 11q23 chromosomal abnormality * Complete response at least 4 weeks after induction therapy OR requiring at least 2 induction regimens * Second or subsequent remission * No relapsed leukemia refractory to appropriate salvage therapy * Availability of an HLA-mismatched family donor * Donor age 75 or under * No better donor alternative (i.e., HLA-matched related or unrelated stem cell donor) is available PATIENT CHARACTERISTICS: Age * 10 to 50 Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * See Disease Characteristics Hepatic * Bilirubin no greater than 4 mg/dL * Transaminases no greater than 3 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * LVEF at least 40% Pulmonary * DLCO at least 65% of predicted Other * Not pregnant * Negative pregnancy test * HIV negative * No other prior malignancy except basal cell or squamous cell skin cancer or a remote history of cancer now considered cured * No major organ dysfunction that would preclude transplantation * No major anticipated illness or organ failure that would preclude transplantation * No severe psychiatric illness or mental deficiency that would preclude giving informed consent or complying with study * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

NIH - Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Myelodysplastic-Myeloproliferative Diseases; Thrombocythemia, Essential; Polycythemia Vera; Blast Crisis; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Acute; Primary Myelofibrosis; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Congenital Abnormalities

Interventions

Cyclophosphamide; Cyclosporine; fludarabine phosphate; Methylprednisolone; Thiotepa; Biological Therapy; Bone Marrow Transplantation; Drug Therapy; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Tissue Transplantation; Cell- and Tissue-Based Therapy; Transplantation; Surgical Procedures, Operative; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation

Study Officials

• Bipin N. Savani, MD

  National Heart, Lung, and Blood Institute (NHLBI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Completion: January 1, 2007
• Last Updated: May 1, 2013

Record last verified: 2006-11

Locations

US (1)