Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
NCT ID: NCT05170828
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2022-09-30
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regmin A (RIC)
Pre-transplant conditioning treatment with Fludarabine, Cyclophosphamide, and Total Body Irradiation (TBI)
Cyclophosphamide
pre-transplant conditioning treatment
Fludarabine
pre-transplant conditioning treatment
Total Body Irradiation
pre-transplant conditioning treatment
Mesna
given with cyclophosphamide
Sirolimus
post-transplant treatment for GVHD
Mycophenolate Mofetil
post-transplant treatment for GVHD
Filgrastim
post-transplant treatment for GVHD
Cyclophosphamide
post-transplant treatment for GVHD
Bone Marrow Transplant
Transplant with investigational bone marrow product
Regimen B (FIC)
Pre-transplant conditioning treatment with Busulfan and Cyclophosphamide OR Fludarabine
Cyclophosphamide
pre-transplant conditioning treatment
Fludarabine
pre-transplant conditioning treatment
Busulfan
pre-transplant conditioning treatment
Mesna
given with cyclophosphamide
Sirolimus
post-transplant treatment for GVHD
Mycophenolate Mofetil
post-transplant treatment for GVHD
Filgrastim
post-transplant treatment for GVHD
Cyclophosphamide
post-transplant treatment for GVHD
Bone Marrow Transplant
Transplant with investigational bone marrow product
Regimen C (FIC)
Pre-transplant conditioning treatment with Cyclophosphamide and Total Body Irradiation (TBI)
Cyclophosphamide
pre-transplant conditioning treatment
Total Body Irradiation
pre-transplant conditioning treatment
Mesna
given with cyclophosphamide
Sirolimus
post-transplant treatment for GVHD
Mycophenolate Mofetil
post-transplant treatment for GVHD
Filgrastim
post-transplant treatment for GVHD
Cyclophosphamide
post-transplant treatment for GVHD
Bone Marrow Transplant
Transplant with investigational bone marrow product
Interventions
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Cyclophosphamide
pre-transplant conditioning treatment
Fludarabine
pre-transplant conditioning treatment
Total Body Irradiation
pre-transplant conditioning treatment
Busulfan
pre-transplant conditioning treatment
Mesna
given with cyclophosphamide
Sirolimus
post-transplant treatment for GVHD
Mycophenolate Mofetil
post-transplant treatment for GVHD
Filgrastim
post-transplant treatment for GVHD
Cyclophosphamide
post-transplant treatment for GVHD
Bone Marrow Transplant
Transplant with investigational bone marrow product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Center for International Blood and Marrow Transplant Research
NETWORK
Ossium Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Auletta, MD
Role: STUDY_CHAIR
Center for International Blood and Marrow Transplant Research
References
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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.
Other Identifiers
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PRESERVE
Identifier Type: -
Identifier Source: org_study_id
NCT05068401
Identifier Type: -
Identifier Source: nct_alias
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