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Cryopreserved MMUD BM With PTCy for Hematologic Malignancies

Primary Purpose

Acute Leukemia, Myelodysplastic Syndromes, T-lymphoblastic Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
Fludarabine
Total Body Irradiation
Busulfan
Mesna
Sirolimus
Mycophenolate Mofetil
Filgrastim
Cyclophosphamide
Bone Marrow Transplant
Sponsored by
Ossium Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring Leukemia, MDS, T-LBL, ALL, AML, ABL, AUL, Bone marrow transplant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 18 and < 71 years (Note: HIV-negative subjects with MDS must be aged <50 at the time of signing the informed consent form)
  • Diagnosed with
  • Acute leukemias or T-lymphoblastic lymphoma (T-LBL) in 1st or subsequent CR
  • Acute lymphocytic leukemia (ALL) or T-LBL as defined by the following:
  • < 5% blasts in the bone marrow
  • Normal maturation of all cellular components in the bone marrow
  • No currently active extramedullary disease (EMD) (e.g., central nervous system (CNS), soft tissue disease)
  • ANC ≥ 1,000/mm3
  • Acute myeloid leukemia (AML) defined by the following:
  • < 5% blasts in the bone marrow
  • No blasts with Auer rods
  • Normal maturation of all cellular components in the bone marrow
  • No currently active EMD (e.g., CNS, soft tissue disease)
  • ANC ≥ 1,000/mm3
  • Acute biphenotypic leukemia (ABL)/Acute undifferentiated leukemia (AUL) defined by the following:
  • < 5% blasts in the bone marrow
  • Normal maturation of all cellular components in the bone marrow
  • No currently active EMD (e.g., CNS, soft tissue disease)
  • ANC ≥ 1,000/mm3
  • Myleodysplastic Syndromes (MDS), fulfilling the following criteria:
  • Subjects with de novo MDS who have or have previously had Intermediate-2 or High-risk disease as determined by the IPSS. Current Intermediate-2 or High- risk disease is not a requirement
  • Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent
  • Subjects may have received prior therapy for the treatment of MDS prior to enrollment
  • Performance status: Karnofsky ≥ 60%
  • Adequate organ function defined as:
  • Cardiac: LVEF at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or LVFS ≥ 25%
  • Pulmonary: DLCO, FEV1, FVC ≥ 50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected or uncorrected for hemoglobin
  • Hepatic: total bilirubin ≤ 2.5 mg/dL, and ALT, AST, and ALP < 5 x ULN (unless ALT, AST, and/or ALP are disease related)
  • Renal: SCr within normal range for age (see table 5.1B). If SCr is outside normal range for age, CrCl > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)
  • Subjects must have the ability to give informed consent according to applicable regulatory and local institutional requirements
  • Availability of deceased HLA MMUD cryopreserved product through Ossium cryobank
  • HLA MMUD defined as 4-7/8 HLA-allele matching at MHC class (A, B, or C) or MHC class II (DRB1)
  • Additional MHC class II HLA (DP and DQ) typing will be collected, but not incorporated in donor selection

Exclusion Criteria:

  • Pediatric patients (17 years or younger)
  • Suitable HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor excluding Ossium product
  • Autologous HCT < 3 months prior to the time of signing the informed consent form
  • Pregnancy or lactation
  • Treatment with an investigational drug or other interventional GVHD clinical trials
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
  • Prior allogeneic HCT
  • Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera
  • Subjects with MDS may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
  • Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Regmin A (RIC)

    Regimen B (FIC)

    Regimen C (FIC)

    Arm Description

    Pre-transplant conditioning treatment with Fludarabine, Cyclophosphamide, and Total Body Irradiation (TBI)

    Pre-transplant conditioning treatment with Busulfan and Cyclophosphamide OR Fludarabine

    Pre-transplant conditioning treatment with Cyclophosphamide and Total Body Irradiation (TBI)

    Outcomes

    Primary Outcome Measures

    Neutrophil engraftment
    Run-in safety phase primary endpoint; Neutrophil engraftment is defined as neutrophil recovery by Day 35. Neutrophil recovery is defined as donor-derived absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive days with evidence of donor chimerism in bone marrow or peripheral blood. Full donor chimerism is >95%, and mixed donor chimerism is defined as 5-95%.
    Cumulative incidence and kinetics of neutrophil and platelet recovery
    Main phase primary endpoint; Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For subjects who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day 1 post-transplant. Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For subjects who never drop their platelet count below 20,000/mm3, the date of platelet recovery will be Day 1 post HCT.
    Overall survival (OS)
    Main phase primary endpoint; The primary endpoint for the study is OS at 1-year post-HCT. The event is death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). Subjects who are lost to follow-up prior to 1-year will be censored at the time of the last observation, and the OS probability will be estimated using the Kaplan-Meier method.

    Secondary Outcome Measures

    Cumulative incidences of aGVHD and cGVHD
    aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV. cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe).
    Transplant-related mortality (TRM)
    TRM is defined as death without evidence of disease progression or recurrence. TRM will be evaluated at Day 100, 180, and 1-year (Day 365).
    NK, B- and T-cell immune reconstitution
    Quantitative assessments of peripheral blood CD3, CD4, CD8, CD19 positive lymphocytes will be done through flow cytometric analysis at Days 35, 100, 180, and 365 post-HCT. Qualitative assessments will be tabulated according to time from transplant.
    Progression free survival (PFS)
    Progression free survival will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as disease relapse or progression, or death by any cause.
    Event free survival (EFS)
    EFS will be estimated at 12 months post-HCT. An event for this time to event outcome includes graft failure (PGF by Day 35 or secondary graft failure), relapse or progression of underlying disease, death, grade III-IV acute GVHD, or NIH-severe chronic GVHD.
    GVHD relapse free survival (GRFS)
    GRFS will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.
    Cumulative incidence of cytokine release syndrome (CRS)
    Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant will be reported on all patients. CRS will be defined and graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
    Donor chimerism
    Peripheral blood chimerism (% of donor chimerism) in whole blood (unsorted) will be described on Day 35, 56, 100, 180, and 1-year (Day 365). Donor cell engraftment will be assessed with donor/recipient chimerism studies at Day 100. Chimerism may be assessed in CD3 blood cell fraction. For the purpose of this protocol, mixed chimerism is defined as the presence of donor cells, as a proportion of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% by Day 35 will be considered as graft rejection. The proportion of patients with each level of chimerism described above will be described as part of this outcome. For sorted blood cell fractions, CD3+ donor cell chimerism will be used to define the donor/recipient chimerism status.
    Cumulative incidences of viral reactivations and infections
    The incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV), BK virus, Adenovirus (ADV), and Human herpesvirus (HHV-6) viral activations and infections at Days 100, 180 and 1-year (Day 365).
    Cumulative incidence of primary disease relapse/progression
    Testing for recurrent malignancy in the blood, bone marrow or other sites will be used to assess relapse and progression post-HCT. For the purpose of this study, relapse is defined by either morphological, cytogenetic/molecular or radiological evidence of disease consistent with pre-HCT features, in line with institutional standards. The event for this endpoint is the time interval from HCT to relapse/recurrence of disease or to last follow-up through 1-year (Day 365) post-HCT. Death in remission is considered a competing risk.

    Full Information

    First Posted
    November 12, 2021
    Last Updated
    December 8, 2021
    Sponsor
    Ossium Health, Inc.
    Collaborators
    Center for International Blood and Marrow Transplant Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05170828
    Brief Title
    Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
    Official Title
    PRESERVE: A Multi-Center Trial Using Banked, Cryopreserved HLA-Mismatched Unrelated Donor Bone Marrow and Post-Transplantation Cyclophosphamide in Allogeneic Transplantation for Patients With Hematologic Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ossium Health, Inc.
    Collaborators
    Center for International Blood and Marrow Transplant Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Multicenter single arm study to assess the safety and efficacy of allogeneic transplantation using cryopreserved bone marrow from deceased MMUD and PTCy, sirolimus and MMF for GVHD prophylaxis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Leukemia, Myelodysplastic Syndromes, T-lymphoblastic Lymphoma, Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Acute Undifferentiated Leukemia
    Keywords
    Leukemia, MDS, T-LBL, ALL, AML, ABL, AUL, Bone marrow transplant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Regmin A (RIC)
    Arm Type
    Other
    Arm Description
    Pre-transplant conditioning treatment with Fludarabine, Cyclophosphamide, and Total Body Irradiation (TBI)
    Arm Title
    Regimen B (FIC)
    Arm Type
    Other
    Arm Description
    Pre-transplant conditioning treatment with Busulfan and Cyclophosphamide OR Fludarabine
    Arm Title
    Regimen C (FIC)
    Arm Type
    Other
    Arm Description
    Pre-transplant conditioning treatment with Cyclophosphamide and Total Body Irradiation (TBI)
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Other Intervention Name(s)
    Cytoxan
    Intervention Description
    pre-transplant conditioning treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Fludarabine
    Other Intervention Name(s)
    Fludara
    Intervention Description
    pre-transplant conditioning treatment
    Intervention Type
    Radiation
    Intervention Name(s)
    Total Body Irradiation
    Other Intervention Name(s)
    TBI
    Intervention Description
    pre-transplant conditioning treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Busulfan
    Other Intervention Name(s)
    Busulfelx
    Intervention Description
    pre-transplant conditioning treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Mesna
    Other Intervention Name(s)
    Mesnex
    Intervention Description
    given with cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    Sirolimus
    Intervention Description
    post-transplant treatment for GVHD
    Intervention Type
    Drug
    Intervention Name(s)
    Mycophenolate Mofetil
    Other Intervention Name(s)
    MMF
    Intervention Description
    post-transplant treatment for GVHD
    Intervention Type
    Drug
    Intervention Name(s)
    Filgrastim
    Other Intervention Name(s)
    G-CSF
    Intervention Description
    post-transplant treatment for GVHD
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Other Intervention Name(s)
    Cytoxan
    Intervention Description
    post-transplant treatment for GVHD
    Intervention Type
    Procedure
    Intervention Name(s)
    Bone Marrow Transplant
    Other Intervention Name(s)
    Hematopoietic Stem Cell Transplant
    Intervention Description
    Transplant with investigational bone marrow product
    Primary Outcome Measure Information:
    Title
    Neutrophil engraftment
    Description
    Run-in safety phase primary endpoint; Neutrophil engraftment is defined as neutrophil recovery by Day 35. Neutrophil recovery is defined as donor-derived absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive days with evidence of donor chimerism in bone marrow or peripheral blood. Full donor chimerism is >95%, and mixed donor chimerism is defined as 5-95%.
    Time Frame
    Day 35 Post HCT
    Title
    Cumulative incidence and kinetics of neutrophil and platelet recovery
    Description
    Main phase primary endpoint; Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For subjects who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day 1 post-transplant. Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For subjects who never drop their platelet count below 20,000/mm3, the date of platelet recovery will be Day 1 post HCT.
    Time Frame
    Day 35 Post HCT
    Title
    Overall survival (OS)
    Description
    Main phase primary endpoint; The primary endpoint for the study is OS at 1-year post-HCT. The event is death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). Subjects who are lost to follow-up prior to 1-year will be censored at the time of the last observation, and the OS probability will be estimated using the Kaplan-Meier method.
    Time Frame
    1-year Post HCT
    Secondary Outcome Measure Information:
    Title
    Cumulative incidences of aGVHD and cGVHD
    Description
    aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV. cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe).
    Time Frame
    1-year Post HCT
    Title
    Transplant-related mortality (TRM)
    Description
    TRM is defined as death without evidence of disease progression or recurrence. TRM will be evaluated at Day 100, 180, and 1-year (Day 365).
    Time Frame
    Day 100 and 1-year Post HCT
    Title
    NK, B- and T-cell immune reconstitution
    Description
    Quantitative assessments of peripheral blood CD3, CD4, CD8, CD19 positive lymphocytes will be done through flow cytometric analysis at Days 35, 100, 180, and 365 post-HCT. Qualitative assessments will be tabulated according to time from transplant.
    Time Frame
    Days 35, 100, 180, and 1-year Post HCT
    Title
    Progression free survival (PFS)
    Description
    Progression free survival will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as disease relapse or progression, or death by any cause.
    Time Frame
    1-year Post HCT
    Title
    Event free survival (EFS)
    Description
    EFS will be estimated at 12 months post-HCT. An event for this time to event outcome includes graft failure (PGF by Day 35 or secondary graft failure), relapse or progression of underlying disease, death, grade III-IV acute GVHD, or NIH-severe chronic GVHD.
    Time Frame
    1-year Post HCT
    Title
    GVHD relapse free survival (GRFS)
    Description
    GRFS will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.
    Time Frame
    1-year Post HCT
    Title
    Cumulative incidence of cytokine release syndrome (CRS)
    Description
    Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant will be reported on all patients. CRS will be defined and graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
    Time Frame
    Day 14 Post HCT
    Title
    Donor chimerism
    Description
    Peripheral blood chimerism (% of donor chimerism) in whole blood (unsorted) will be described on Day 35, 56, 100, 180, and 1-year (Day 365). Donor cell engraftment will be assessed with donor/recipient chimerism studies at Day 100. Chimerism may be assessed in CD3 blood cell fraction. For the purpose of this protocol, mixed chimerism is defined as the presence of donor cells, as a proportion of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% by Day 35 will be considered as graft rejection. The proportion of patients with each level of chimerism described above will be described as part of this outcome. For sorted blood cell fractions, CD3+ donor cell chimerism will be used to define the donor/recipient chimerism status.
    Time Frame
    Days 35, 56, 100, 180, and 1-year Post HCT
    Title
    Cumulative incidences of viral reactivations and infections
    Description
    The incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV), BK virus, Adenovirus (ADV), and Human herpesvirus (HHV-6) viral activations and infections at Days 100, 180 and 1-year (Day 365).
    Time Frame
    Days 100, 180, and 1-year Post HCT
    Title
    Cumulative incidence of primary disease relapse/progression
    Description
    Testing for recurrent malignancy in the blood, bone marrow or other sites will be used to assess relapse and progression post-HCT. For the purpose of this study, relapse is defined by either morphological, cytogenetic/molecular or radiological evidence of disease consistent with pre-HCT features, in line with institutional standards. The event for this endpoint is the time interval from HCT to relapse/recurrence of disease or to last follow-up through 1-year (Day 365) post-HCT. Death in remission is considered a competing risk.
    Time Frame
    1-year Post HCT
    Other Pre-specified Outcome Measures:
    Title
    Length of stay in hospital
    Description
    Cumulative days alive and out of the hospital in the first 100 days and in the first year post-transplant.
    Time Frame
    Day 100 Post HCT
    Title
    Incidence of clinically-significant infections
    Description
    A clinically significant infection is defined as an infection that requires therapeutic intervention.
    Time Frame
    1-year Post HCT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged ≥ 18 and < 71 years (Note: HIV-negative subjects with MDS must be aged <50 at the time of signing the informed consent form) Diagnosed with Acute leukemias or T-lymphoblastic lymphoma (T-LBL) in 1st or subsequent CR Acute lymphocytic leukemia (ALL) or T-LBL as defined by the following: < 5% blasts in the bone marrow Normal maturation of all cellular components in the bone marrow No currently active extramedullary disease (EMD) (e.g., central nervous system (CNS), soft tissue disease) ANC ≥ 1,000/mm3 Acute myeloid leukemia (AML) defined by the following: < 5% blasts in the bone marrow No blasts with Auer rods Normal maturation of all cellular components in the bone marrow No currently active EMD (e.g., CNS, soft tissue disease) ANC ≥ 1,000/mm3 Acute biphenotypic leukemia (ABL)/Acute undifferentiated leukemia (AUL) defined by the following: < 5% blasts in the bone marrow Normal maturation of all cellular components in the bone marrow No currently active EMD (e.g., CNS, soft tissue disease) ANC ≥ 1,000/mm3 Myleodysplastic Syndromes (MDS), fulfilling the following criteria: Subjects with de novo MDS who have or have previously had Intermediate-2 or High-risk disease as determined by the IPSS. Current Intermediate-2 or High- risk disease is not a requirement Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent Subjects may have received prior therapy for the treatment of MDS prior to enrollment Performance status: Karnofsky ≥ 60% Adequate organ function defined as: Cardiac: LVEF at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or LVFS ≥ 25% Pulmonary: DLCO, FEV1, FVC ≥ 50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected or uncorrected for hemoglobin Hepatic: total bilirubin ≤ 2.5 mg/dL, and ALT, AST, and ALP < 5 x ULN (unless ALT, AST, and/or ALP are disease related) Renal: SCr within normal range for age (see table 5.1B). If SCr is outside normal range for age, CrCl > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula) Subjects must have the ability to give informed consent according to applicable regulatory and local institutional requirements Availability of deceased HLA MMUD cryopreserved product through Ossium cryobank HLA MMUD defined as 4-7/8 HLA-allele matching at MHC class (A, B, or C) or MHC class II (DRB1) Additional MHC class II HLA (DP and DQ) typing will be collected, but not incorporated in donor selection Exclusion Criteria: Pediatric patients (17 years or younger) Suitable HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor excluding Ossium product Autologous HCT < 3 months prior to the time of signing the informed consent form Pregnancy or lactation Treatment with an investigational drug or other interventional GVHD clinical trials Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings) Prior allogeneic HCT Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera Subjects with MDS may not receive RIC and must be < 50 years of age at the time of signing the informed consent form Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shannon Clark, MS
    Phone
    6124025362
    Email
    sclark2@nmdp.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffery Auletta, MD
    Organizational Affiliation
    Center for International Blood and Marrow Transplant Research
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    36402456
    Citation
    Johnstone BH, Woods JR, Goebel WS, Gu D, Lin CH, Miller HM, Musall KG, Sherry AM, Bailey BJ, Sims E, Sinn AL, Pollok KE, Spellman S, Auletta JJ, Woods EJ. Characterization and Function of Cryopreserved Bone Marrow from Deceased Organ Donors: A Potential Viable Alternative Graft Source. Transplant Cell Ther. 2023 Feb;29(2):95.e1-95.e10. doi: 10.1016/j.jtct.2022.11.010. Epub 2022 Nov 17.
    Results Reference
    derived

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    Cryopreserved MMUD BM With PTCy for Hematologic Malignancies

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