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Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer

Primary Purpose

Chronic Myeloproliferative Disorders, Leukemia, Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
cyclosporine
mycophenolate mofetil
pentostatin
cytogenetic analysis
fluorescence in situ hybridization
protein analysis
flow cytometry
immunoenzyme technique
laboratory biomarker analysis
reduced-intensity transplant conditioning procedure
nonmyeloablative allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation (PBSC)
total-body irradiation
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, essential thrombocythemia, polycythemia vera, primary myelofibrosis, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, marginal zone B-cell lymphoma of mucosal lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, aplastic anemia, chronic eosinophilic leukemia, chronic neutrophilic leukemia, contiguous st II adult diffuse small cleaved cell lymphoma, noncontig stage II adult diffuse small cleaved cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of a confirmed hematological malignancy that has relapsed or is at high risk for relapsing, including any of the following:

    • Acute myeloid leukemia (AML) meeting any of the following criteria:

      • Antecedent hematologic disorder
      • Therapy related
      • Primary induction failure
      • In first complete remission (CR1) with poor-risk cytogenetics, as defined by the following:

        • del(5q)/-5
        • del(7q)/-7
        • abn(3q)
        • t(6;9)
        • del(20q)
        • del(17p)
        • +13
        • Complex karyotype
        • t(9;22) = 11q23 rearrangement
      • In second complete remission (CR2) or greater
    • Acute lymphoblastic leukemia meeting any of the following criteria:

      • In CR1 with WBC > 50,000/mm³ at diagnosis
      • In CR1 with poor-risk cytogenetics (i.e., t[9;22], t[1;19], t[4;11]) AND meets at least 1 of the following criteria:

= 19-75 years of age AND received prior high-dose chemotherapy, total-body irradiation (TBI), or a radiation dose that precludes administration of 12 Gy of TBI = 50-75 years of age = 19-75 years of age with hematopoietic stem cell transplantation (HSCT) comorbidity index ≥ 3

  • CNS or testicular involvement at diagnosis
  • No CR within 4 weeks of initial treatment
  • Primary induction failure
  • In CR2 or greater

    • Myelodysplastic syndromes meeting the following criteria:
  • Intermediate-2 or high-risk category as determined by International Prognostic Scoring System
  • Not considered a candidate for intensive or standard chemotherapy or HSCT

    • Chronic myelogenous leukemia meeting any of the following criteria:
  • First chronic phase AND < 40 years of age
  • First chronic phase AND no hematologic response after 3 months of imatinib mesylate therapy
  • First chronic phase AND never achieved a complete cytogenetic response during imatinib mesylate therapy
  • First chronic phase AND loss of previously documented response
  • Accelerated phase
  • Blast crisis phase

    • Chronic myeloproliferative disorder (i.e., polycythemia vera, essential thrombocythemia, myelofibrosis)
  • Bone marrow blasts > 5% and/or other evidence of progression to acute leukemia

    • Chronic myelomonocytic leukemia
    • Severe aplastic anemia
  • Failed prior antithymocyte globulin and cyclosporine immunosuppressive therapy

    • Mantle cell lymphoma meeting any of the following criteria:
  • In CR1
  • In first partial remission (PR1)
  • In CR 2 or greater
  • In second PR (PR2) or greater

    • Indolent non-Hodgkin lymphoma OR chronic lymphocytic leukemia meeting either of the following criteria:
  • In CR 2 or greater
  • In PR 2 or greater

    • Lymphoblastic lymphoma
  • In CR1 or greater

    • Must have minimal residual disease as defined by either of the following:

      • No more than 5% blasts in blood and/or bone marrow (in patients with acute leukemia/MDS)
      • No bulky adenopathy (> 5 cm masses) and/or < 20% bone marrow involvement by lymphoma (in patients with lymphoma)
    • No progressive disease within 8 weeks of most recent prior therapy OR within 12 weeks of prior autologous HSCT
    • No active CNS malignancy (i.e., known positive CSF cytology or parenchymal lesions visible by CT scan or MRI)
    • HLA-matched unrelated peripheral blood stem cell donor available

      • Meets the University of Nebraska Medical Center's or the National Marrow Donor Program's criteria for donors
      • Matched at 7/8 or 8/8 HLA-A, B, C, or DRβ1 loci by molecular typing
  • If match is not at allele level, suitability for donation requires discussion with and approval by the principal investigator

    • Not an identical twin

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Creatinine clearance ≥ 55 mL/min
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or malignancy)
  • ALT and AST ≤ 4 times ULN
  • DLCO ≥ 40%
  • FEV1/FVC ratio ≥ 50% of predicted
  • Cardiac ejection fraction ≥ 40%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Not receiving supplementary continuous oxygen
  • No NYHA grade II-IV cardiac disease
  • HIV negative
  • No evidence of active hepatitis B (i.e., positive HBsAg and/or positive HBeAg or high copy number on quantitative RNA testing) or hepatitis C
  • No active uncontrolled infection or immediate life-threatening condition
  • No uncontrolled medical illnesses (e.g., uncontrolled systemic hypertension or diabetes)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior cytoreductive chemotherapy or irradiation to areas of bulky disease allowed, as determined by the primary physician in consultation with the study investigators
  • No other concurrent anti-tumor therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer

    Arm Description

    This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.

    Outcomes

    Primary Outcome Measures

    Severe transplant-related toxicity
    Severe transplant-related toxicity (grade III-IV adverse events) as assessed by NCI CTCAE v2.0
    Stable donor engraftment
    Stable donor engraftment
    Mortality
    Death

    Secondary Outcome Measures

    Incidence of grade III-IV acute graft-versus-host disease
    An interim analysis will be performed after the accrual of each five patients (i.e., three interim analyses and 1 final analysis) has reached day 100.

    Full Information

    First Posted
    December 31, 2008
    Last Updated
    August 10, 2023
    Sponsor
    University of Nebraska
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00816413
    Brief Title
    Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer
    Official Title
    T Cell-Reduced Unrelated Donor Allogeneic Peripheral Blood Stem Cell Transplantation With Pentostatin and Low-Dose Total Body Irradiation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Screenings yielded inadequate eligible subjects to enroll.
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant and giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
    Detailed Description
    OBJECTIVES: Primary To determine the safety of pentostatin and low-dose total body irradiation followed by T-cell-reduced unrelated donor peripheral blood stem cell transplantation, in terms of regimen-related toxicity, in patients with hematological malignancies. To evaluate the efficacy of this regimen, measured as engraftment rate and establishment of donor hematopoietic chimerism, in these patients. Secondary To determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen. OUTLINE: Reduced-intensity preparative regimen: Patients receive pentostatin IV over 30 minutes once daily on days -10 to -8 and undergo low-dose total-body irradiation on day -1. Unrelated donor peripheral blood stem cell transplantation (PBSCT): Patients undergo T-cell-reduced donor PBSCT on day 0. Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours twice daily on days -1, 0, and 1 and then orally twice daily on days 2-70 followed by a taper in the absence of GVHD. Patients also receive oral mycophenolate mofetil twice daily on days 0-27 followed by a taper. Patients undergo bone marrow aspirate and biopsies and blood sample collection periodically for laboratory studies. Samples are analyzed for cytokines (i.e., IL-6, TNF-γ, IL-1β, and IL-10) by ELISA; phenotypic, molecular, and functional analysis of immunologic reconstitution markers (i.e., PHA, IL-2, IL-4, IL-10, IL-12, Fas, FasL, TNF, TGF-β, and IFN-γ) by flow cytometry; and cytogenetics by FISH. After completion of study treatment, patients are followed periodically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Nonmalignant Neoplasm
    Keywords
    adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, essential thrombocythemia, polycythemia vera, primary myelofibrosis, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, marginal zone B-cell lymphoma of mucosal lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, aplastic anemia, chronic eosinophilic leukemia, chronic neutrophilic leukemia, contiguous st II adult diffuse small cleaved cell lymphoma, noncontig stage II adult diffuse small cleaved cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
    Arm Type
    Experimental
    Arm Description
    This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
    Intervention Type
    Drug
    Intervention Name(s)
    cyclosporine
    Other Intervention Name(s)
    Gengraf, Neoral, and Sandimmune
    Intervention Description
    2 mg/kg IV over 2 hours every 12 hours starting at 0700 on days -1, 0, and +1 (total of six doses).
    Intervention Type
    Drug
    Intervention Name(s)
    mycophenolate mofetil
    Other Intervention Name(s)
    CellCept
    Intervention Description
    15 mg/kg orally twice a day starting day 0 until day +27 then stopped without tapering in the absence of aGVHD then tapered over two months in the absence of aGVHD. Doses will be rounded to the nearest 250 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    pentostatin
    Other Intervention Name(s)
    Nipent
    Intervention Description
    4 mg/m2/d IV over 30 minutes daily x 3 days, (days -10, -9, -8)to begin ten days prior to stem cell infusion (Day 0).
    Intervention Type
    Genetic
    Intervention Name(s)
    cytogenetic analysis
    Intervention Description
    At days +28 and +70 post-transplant, patients' blood will be evaluated for CD3 and overall WBC chimerism.
    Intervention Type
    Genetic
    Intervention Name(s)
    fluorescence in situ hybridization
    Intervention Description
    Mixed chimerism is defined as the detection of 95% or less donor T cells (CD3+), expressed as a proportion of the total T cell and WBC population as measured by DNA.
    Intervention Type
    Genetic
    Intervention Name(s)
    protein analysis
    Intervention Description
    Blood samples will be at baseline(day -11 or before) , days -8 and -1, prior to transplant on day 0, then weekly (days +7, +14, +21 and +28) post-transplant through day +28. Five ml's of blood will be drawn at each collection through a central line using heparinized vaccutainers. Samples will be spun down at 1200 g and plasma aspirated and stored in -80 oC until analyzed for the ELISA Assays being done for research purposes in this protocol.
    Intervention Type
    Other
    Intervention Name(s)
    flow cytometry
    Intervention Description
    Peripheral blood Peripheral blood flow cytometry for immunophenotyping including Th/c1 and Th/c2 subsets, mitogens (PHA, PWM), NK and LAK function studies, DCs, apoptosis assay of tumor cells, and lymphocyte subsets (CD4, CD8, CD19, CD56
    Intervention Type
    Other
    Intervention Name(s)
    immunoenzyme technique
    Intervention Description
    Peripheral blood for immunophenotyping including Th/c1 and Th/c2 subsets, mitogens (PHA, PWM), NK and LAK function studies, DCs, apoptosis assay of tumor cells, and lymphocyte subsets (CD4, CD8, CD19, CD56
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Donor mononuclear cells from the stem cell product (SCP) obtained with apheresis will be analyzed for surface markers, including CD3, CD4, CD8, CD19, CD14, CD56, TCR+CD8+ cells, Th/c1 and Th/c2, Fas and FasL, and DCs, as well as for apoptosis
    Intervention Type
    Other
    Intervention Name(s)
    reduced-intensity transplant conditioning procedure
    Intervention Description
    Allopurinol 300 mg orally once daily x 10 days, to begin one day prior to treatment with Pentostatin (day -11 to day -2) . Pentostatin 4 mg/m2/d IV over 30 minutes daily x 3 days, (days -10, -9, -8)to begin ten days prior to stem cell infusion (Day 0) . Pre and Post Pentostatin Hydration: 1000ml Normal Saline IV over 2 hours pre each dose of Pentostatin and 1000ml Normal Saline IV over 4 hours post each dose of Pentostatin on days -10, -9, -8. Pre Pentostatin Recommended Antiemetics: Ondansetron 32 mg IV over 30 minutes to be given 30 min. before each dose of Pentostatin on days -10, -9, -8. Alternative ondansetron equivalent or other ancillary antiemetics may be used at the discretion of the treating physician. Pred Forte Eye Drops: two drops in each eye every 4 hours while awake x 7 days after starting Pentostatin (day -10 to day -4).
    Intervention Type
    Procedure
    Intervention Name(s)
    nonmyeloablative allogeneic hematopoietic stem cell transplantation
    Intervention Description
    Each patient will receive up to four IV infusions administered over 30 minutes of donor T cells at increasing cell doses given at intervals.
    Intervention Type
    Procedure
    Intervention Name(s)
    peripheral blood stem cell transplantation (PBSC)
    Intervention Description
    PBSC are infused intravenously either by infusion or IV push on day 0 through a secure intravenous access (i.e. the double-lumen central catheter place pre transplant) according to institutional guidelines.
    Intervention Type
    Radiation
    Intervention Name(s)
    total-body irradiation
    Intervention Description
    2.0 GY will be administered on day -1. Total-body irradiation (TBI) will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. It is anticipated that TBI will be given on day -1; however, the timing of TBI administration may be altered by factors beyond the control of the Principal Investigator because of the delivery of unrelated donor stem cells.
    Primary Outcome Measure Information:
    Title
    Severe transplant-related toxicity
    Description
    Severe transplant-related toxicity (grade III-IV adverse events) as assessed by NCI CTCAE v2.0
    Time Frame
    before day 100
    Title
    Stable donor engraftment
    Description
    Stable donor engraftment
    Time Frame
    by day 70
    Title
    Mortality
    Description
    Death
    Time Frame
    at day 100
    Secondary Outcome Measure Information:
    Title
    Incidence of grade III-IV acute graft-versus-host disease
    Description
    An interim analysis will be performed after the accrual of each five patients (i.e., three interim analyses and 1 final analysis) has reached day 100.
    Time Frame
    at day 100

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria • Diagnosis of a confirmed hematological malignancy that has relapsed or is at high risk for relapsing, including any of the following: Acute myeloid leukemia (AML) meeting any of the following criteria: Antecedent hematologic disorder Therapy related Primary induction failure In first complete remission (CR1) with poor-risk cytogenetics, as defined by the following: del(5q)/-5 del(7q)/-7 abn(3q) t(6;9) del(20q) del(17p) +13 Complex karyotype t(9;22) = 11q23 rearrangement In second complete remission (CR2) or greater Acute lymphoblastic leukemia meeting any of the following criteria: In CR1 with WBC > 50,000/mm³ at diagnosis In CR1 with poor-risk cytogenetics (i.e., t[9;22], t[1;19], t[4;11]) AND meets at least 1 of the following criteria: 19-75 years of age AND received prior high-dose chemotherapy, total-body irradiation (TBI), or a radiation dose that precludes administration of 12 Gy of TBI = 50-75 years of age = 19-75 years of age with hematopoietic stem cell transplantation (HSCT) comorbidity index ≥ 3 CNS or testicular involvement at diagnosis No CR within 4 weeks of initial treatment Primary induction failure In CR2 or greater Myelodysplastic syndromes meeting the following criteria: Intermediate-2 or high-risk category as determined by International Prognostic Scoring System Not considered a candidate for intensive or standard chemotherapy or HSCT Chronic myelogenous leukemia meeting any of the following criteria: First chronic phase AND < 40 years of age First chronic phase AND no hematologic response after 3 months of imatinib mesylate therapy First chronic phase AND never achieved a complete cytogenetic response during imatinib mesylate therapy First chronic phase AND loss of previously documented response Accelerated phase Blast crisis phase Chronic myeloproliferative disorder (i.e., polycythemia vera, essential thrombocythemia, myelofibrosis) Bone marrow blasts > 5% and/or other evidence of progression to acute leukemia Chronic myelomonocytic leukemia Severe aplastic anemia Failed prior antithymocyte globulin and cyclosporine immunosuppressive therapy Mantle cell lymphoma meeting any of the following criteria: In CR1 In first partial remission (PR1) In CR2 or greater In second PR (PR2) or greater Indolent non-Hodgkin lymphoma OR chronic lymphocytic leukemia meeting either of the following criteria: In CR2 or greater In PR2 or greater Lymphoblastic lymphoma In CR1 or greater Must have minimal residual disease as defined by either of the following: No more than 5% blasts in blood and/or bone marrow (in patients with acute leukemia/MDS) No bulky adenopathy (> 5 cm masses) and/or < 20% bone marrow involvement by lymphoma (in patients with lymphoma) No progressive disease within 8 weeks of most recent prior therapy OR within 12 weeks of prior autologous HSCT No active CNS malignancy (i.e., known positive CSF cytology or parenchymal lesions visible by CT scan or MRI) HLA-matched unrelated peripheral blood stem cell donor available Meets the University of Nebraska Medical Center's or the National Marrow Donor Program's criteria for donors Matched at 7/8 or 8/8 HLA-A, B, C, or DRβ1 loci by molecular typing If match is not at allele level, suitability for donation requires discussion with and approval by the principal investigator Not an identical twin Karnofsky performance status 60-100% Creatinine clearance ≥ 55 mL/min Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or malignancy) ALT and AST ≤ 4 times ULN DLCO ≥ 40% FEV1/FVC ratio ≥ 50% of predicted Cardiac ejection fraction ≥ 40%Prior cytoreductive chemotherapy or irradiation to areas of bulky disease allowed, as determined by the primary physician in consultation with the study investigators Exclusion Criteria No CR within 4 weeks of initial treatment No other concurrent anti-tumor therapy Not pregnant or nursing (fertile patients must use effective contraception) Not receiving supplementary continuous oxygen No NYHA grade II-IV cardiac disease HIV positive Active hepatitis B (i.e., positive HBsAg and/or positive HBeAg or high copy number on quantitative RNA testing) or hepatitis C Active uncontrolled infection or immediate life-threatening condition Uncontrolled medical illnesses (e.g., uncontrolled systemic hypertension or diabetes)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Bociek, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer

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