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Status:

COMPLETED

Mismatched Donor Lymphocyte Infusions for Relapsed Disease Following Allogeneic Stem Cell Transplantation

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Leukemia, Myeloid, Acute

Leukemia, Lymphoblastic, Acute

Eligibility:

All Genders

8-75 years

Phase:

NA

Brief Summary

Patients receiving allogeneic stem cell transplantation for hematological malignancies who suffer a relapse of their disease post-transplant have limited treatment options and a poor prognosis. With t...

Detailed Description

Patients receiving allogeneic stem cell transplantation for hematological malignancies who suffer a relapse of their disease post-transplant have limited treatment options and a poor prognosis. With t...

Eligibility Criteria

Inclusion

  • ELIGIBILITY CRITERIA:
  • Inclusion Criteria- Recipient:
  • Diagnosed with one of the following hematological conditions:
  • Acute lymphoblastic leukemia (ALL) of any subtype or
  • Acute myelogenous leukemia (AML) of any subtype or
  • Myelodysplastic syndrome (MDS) of any subtype or
  • Blastic phase Chronic Myeloid Leukemia (CML)
  • Relapsed disease within 6 months of matched sibling allogeneic stem cell transplant procedure
  • Evaluation for protocol within 8 weeks of relapse and enrollment within 12 weeks or relapse
  • 8-75 years of age
  • Availability of previous HLA identical (6/6) related donor (ages 8 to 17 must have previously donated bone marrow \[not peripheral blood\]
  • At least one haploidentical (1-3 antigen mismatched) related donor available for apheresis
  • Exclusion Criteria Recipient (any of the following):
  • Active grade II-IV Graft vs. Host Disease (GvHD)
  • Extensive chronic Graft vs. Host Disease (GvHD)
  • Post-transplant donor lymphocyte infusion (DLI) from original donor within 1 month of protocol enrollment.
  • Progressive disease despite post-relapse chemo or monoclonal therapy.
  • Co-morbidity of such severity that it would preclude the patients ability to tolerate protocol therapy.
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 10 x ULN (grade 3, CTCAE).
  • Bilirubin greater than 5 x Upper Limit of Normal (ULN) (grade 3, CTCAE).
  • Creatinine greater than 3.5 mg/dl (grade 3, CTCAE).
  • HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation).
  • Positive pregnancy test for women of childbearing age.
  • Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
  • Inclusion Criteria- Stem Cell Donors:
  • HLA-matched sibling stem cell donor from the original transplant to participate in a stem cell rescue only in the setting of severe, refractory GvHD caused by the haploidentical cells.
  • Related HLA haplo-identical (1-3 A, B or DR antigens mismatched with recipient). To maximize the GvL that is associated with HLA disparity, the haploidentical donor will be chosen based on the greatest HLA mismatch (preference: 3/6 greater than 4/6 greater than 5/6). Parents and siblings will be considered equally.
  • Weight greater than or equal to 18 kg
  • Age greater than or equal to 8 or less than or equal to 80 years old.
  • Exclusion Criteria Stem Cell Donor (any of the following):
  • Pregnant or lactating
  • Unfit to receive filgrastim (G-CSF) or previous filgrastim mobilization for donors under 18 years of age.
  • Unfit to undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension).
  • Sickling hemoglobinopathies such as HbSS or HbSC.
  • HIV positive. Donors who are positive for hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I/II), or T.cruzi (Chagas) will be used at the discretion of the investigator following counseling and approval from the recipient.
  • Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the donation of stem cells unlikely and/or informed consent impossible.
  • Inclusion criteria- Haplo Lymphocyte Donors:
  • Related HLA haplo-identical (1-3 A, B or DR antigens mismatched with recipient). To maximize the GvL that is associated with HLA disparity, the haploidentical donor will be chosen based on the greatest HLA mismatch (preference: 3/6 greater than 4/6 greater than 5/6). Donors age less than 80 years required, and parents and siblings will be considered equally.
  • Age greater than or equal to 18 or less than or equal to 80 years old.
  • Exclusion Criteria Haplo Lymphocyte Donor (any of the following):
  • Pregnant or lactating
  • Unfit to undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension).
  • Sickling hemoglobinopathies such as HbSS and HbSC .
  • HIV positive. Donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II), or T.cruzi (Chagas) will be used at the discretion of the investigator following counseling and approval from the recipient.
  • Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the donation of stem cells unlikely and/or informed consent impossible

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2014

    Estimated Enrollment :

    8 Patients enrolled

    Trial Details

    Trial ID

    NCT00859586

    Start Date

    February 1 2009

    End Date

    September 1 2014

    Last Update

    October 27 2020

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health

    Bethesda, Maryland, United States, 20852