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

Related Clinical Trial
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Ixazomib (MLN9708) in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia AML Therapy With Irradiated Allogeneic Cells Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study. Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML)

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

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.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Adult Acute Erythroid Leukemia

Intervention

anti-thymocyte globulin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0




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
      

Gender

All

Ages

18 Years - 59 Years

Accepts Healthy Volunteers

No

Contacts

Mark R. Litzow, MD, , 



Administrative Informations


NCT ID

NCT00101140

Organization ID

CDR0000405838

Secondary IDs

ECOG-E1903


Study Sponsor

Eastern Cooperative Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Mark R. Litzow, MD, Study Chair, Mayo Clinic


Verification Date

October 2017