Cryopreserved MMUD BM With PTCy for Hematologic Malignancies (NCT05170828) | Clinical Trial Compass
WithdrawnPhase 1
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
Stopped: Change in Study Design
0Started 2022-09
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Neutrophil engraftment
Timeframe: Day 35 Post HCT
2
Cumulative incidence and kinetics of neutrophil and platelet recovery