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Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders (MINI HEME)

Primary Purpose

AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
fludarabine
cyclosporine
methotrexate
G-CSF
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring AML, ALL, CML, CLL, MDS, NHL, HODGKIN'S LYMPHOMA, APLASTIC ANEMIA, MULTIPLE MYELOMA, MYELOPROLIFERATIVE DISORDER, ALLOGENEIC, STEM CELL TRANSPLANT, HEMATOLOGIC DISORDERS, CYCLOPHOSPHAMIDE, FLUDARABINE, CYCLOSPORINE, METHOTREXATE, G-CSF, GVHD, ENGRAFTMENT, CHIMERISM

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria - Patient:

  • AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET
  • Age less than 65 years
  • Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses
  • Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol

Inclusion Criteria - Donor:

  • Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells
  • Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest
  • Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C
  • The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

Exclusion Criteria - Patient:

  • Active CNS involvement
  • Females who are pregnant or breast feeding
  • ECOG performance status > 1. Karnofsky performance status < 80%
  • LVEF < 40%
  • Active viral, bacterial, or fungal infection
  • Patients seropositive for HIV; HTLV -1
  • Patients not providing informed consent
  • Patients with known hypersensitivity to E. Coli derived product

Exclusion Criteria - Donor:

  • A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Study treatment arm with G-CSF

    Outcomes

    Primary Outcome Measures

    durable engraftment
    hematopoeitic reconstitution
    evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells

    Secondary Outcome Measures

    disease free survival and overall survival
    incidence of treatment related toxicity and acute and chronic graft versus host disease

    Full Information

    First Posted
    March 10, 2008
    Last Updated
    April 5, 2017
    Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00636909
    Brief Title
    Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders
    Acronym
    MINI HEME
    Official Title
    Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1999 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Amgen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, APLASTIC ANEMIA, MULTIPLE MYELOMA, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
    Keywords
    AML, ALL, CML, CLL, MDS, NHL, HODGKIN'S LYMPHOMA, APLASTIC ANEMIA, MULTIPLE MYELOMA, MYELOPROLIFERATIVE DISORDER, ALLOGENEIC, STEM CELL TRANSPLANT, HEMATOLOGIC DISORDERS, CYCLOPHOSPHAMIDE, FLUDARABINE, CYCLOSPORINE, METHOTREXATE, G-CSF, GVHD, ENGRAFTMENT, CHIMERISM

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Study treatment arm with G-CSF
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    preparative cytoreduction
    Intervention Type
    Drug
    Intervention Name(s)
    fludarabine
    Intervention Description
    preparative cytoreduction
    Intervention Type
    Drug
    Intervention Name(s)
    cyclosporine
    Intervention Description
    immunosuppressive therapy
    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Intervention Description
    immunosuppressive therapy
    Intervention Type
    Biological
    Intervention Name(s)
    G-CSF
    Intervention Description
    foster engraftment
    Primary Outcome Measure Information:
    Title
    durable engraftment
    Time Frame
    100 days
    Title
    hematopoeitic reconstitution
    Time Frame
    3 years
    Title
    evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    disease free survival and overall survival
    Time Frame
    3 years
    Title
    incidence of treatment related toxicity and acute and chronic graft versus host disease
    Time Frame
    100 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria - Patient: AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET Age less than 65 years Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol Inclusion Criteria - Donor: Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus. Exclusion Criteria - Patient: Active CNS involvement Females who are pregnant or breast feeding ECOG performance status > 1. Karnofsky performance status < 80% LVEF < 40% Active viral, bacterial, or fungal infection Patients seropositive for HIV; HTLV -1 Patients not providing informed consent Patients with known hypersensitivity to E. Coli derived product Exclusion Criteria - Donor: A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David F McDermott, MD
    Organizational Affiliation
    Beth Israel Deaconess Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David E Avigan, MD
    Organizational Affiliation
    Beth Israel Deaconess Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

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