search
Back to results

Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

Primary Purpose

Adult Acute Erythroid Leukemia, Adult Acute Monoblastic and Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
anti-thymocyte globulin
fludarabine phosphate
thiotepa
biological therapy
bone marrow ablation with stem cell support
chemotherapy
non-specific immune-modulator therapy
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Erythroid Leukemia focused on measuring adult erythroleukemia (M6a), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4)

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes: Acute myeloblastic leukemia (M0, M1, M2) Acute myelomonocytic leukemia (M4) Acute monocytic leukemia (M5) Acute erythroleukemia (M6) Acute megakaryocytic leukemia (M7) Must have 1 of the following karyotypic abnormalities at the time of diagnosis: Complex cytogenetic abnormalities (≥ 3 cytogenetic clones) Abnormalities of chromosome 5 [-5 or del(5q)] Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21 Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8) In morphologic first complete remission*, as evidenced by all of the following for ≥ 4 weeks before study entry: Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Leukemic blasts not present in the peripheral blood Cellularity of bone marrow biopsy > 20% with maturation of all cell lines Less than 5% blasts by bone marrow biopsy No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: *Reduced hemoglobin concentration or hematocrit has no bearing on remission status Haploidentical (3/6 or 4/6 antigen matched [A, B, and DR]) family donor available PATIENT CHARACTERISTICS: Age 18 to 59 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 2.0 mg/dL AST < 2 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular Ejection fraction > 40% by MUGA or echocardiogram None of the following within the past 3 months: Myocardial infarction Significant congestive heart failure Significant cardiac arrhythmia Pulmonary FEV_1 and DLCO > 50% of predicted Immunologic HIV negative No active or unresolved infection No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No organ damage No other medical problem that would preclude study participation No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2005
    Last Updated
    October 18, 2017
    Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00101140
    Brief Title
    Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
    Official Title
    Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.
    Detailed Description
    OBJECTIVES: Primary Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission. Secondary Determine the early treatment-related mortality (before day 100) of patients treated with this regimen. Determine the incidence of acute graft-versus-host disease in patients treated with this regimen. Determine the incidence of graft failure in patients treated with this regimen. Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive a preparative regimen comprising total-body irradiation twice on day -8; fludarabine IV over 30 minutes on days -7 to -3; thiotepa IV over 2 hours twice on day -7; and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0. Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adult Acute Erythroid Leukemia, Adult Acute Monoblastic and Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia
    Keywords
    adult erythroleukemia (M6a), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    anti-thymocyte globulin
    Intervention Type
    Drug
    Intervention Name(s)
    fludarabine phosphate
    Intervention Type
    Drug
    Intervention Name(s)
    thiotepa
    Intervention Type
    Procedure
    Intervention Name(s)
    biological therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    bone marrow ablation with stem cell support
    Intervention Type
    Procedure
    Intervention Name(s)
    chemotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    non-specific immune-modulator therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    peripheral blood stem cell transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes: Acute myeloblastic leukemia (M0, M1, M2) Acute myelomonocytic leukemia (M4) Acute monocytic leukemia (M5) Acute erythroleukemia (M6) Acute megakaryocytic leukemia (M7) Must have 1 of the following karyotypic abnormalities at the time of diagnosis: Complex cytogenetic abnormalities (≥ 3 cytogenetic clones) Abnormalities of chromosome 5 [-5 or del(5q)] Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21 Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8) In morphologic first complete remission*, as evidenced by all of the following for ≥ 4 weeks before study entry: Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Leukemic blasts not present in the peripheral blood Cellularity of bone marrow biopsy > 20% with maturation of all cell lines Less than 5% blasts by bone marrow biopsy No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: *Reduced hemoglobin concentration or hematocrit has no bearing on remission status Haploidentical (3/6 or 4/6 antigen matched [A, B, and DR]) family donor available PATIENT CHARACTERISTICS: Age 18 to 59 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 2.0 mg/dL AST < 2 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular Ejection fraction > 40% by MUGA or echocardiogram None of the following within the past 3 months: Myocardial infarction Significant congestive heart failure Significant cardiac arrhythmia Pulmonary FEV_1 and DLCO > 50% of predicted Immunologic HIV negative No active or unresolved infection No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No organ damage No other medical problem that would preclude study participation No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark R. Litzow, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jacob M. Rowe, MD
    Organizational Affiliation
    Rambam Health Care Campus

    12. IPD Sharing Statement

    Learn more about this trial

    Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

    We'll reach out to this number within 24 hrs