Blood cancer transplant trial using banked donor marrow pulled before start
NCT ID NCT05170828
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 trial aimed to test whether bone marrow from deceased, mismatched unrelated donors could be safely used for transplants in patients with blood cancers like leukemia. The approach used stored (cryopreserved) marrow along with drugs to prevent rejection. However, the study was withdrawn before any participants were enrolled, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryopreserved bone marrow from deceased mismatched unrelated donors
- What this could lead to
- If successful, this approach could expand donor options for blood cancer patients who need a bone marrow transplant but lack a perfect match.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no results exist. The approach is early-stage (Phase 1) and carries risks like graft failure, infection, and graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
-
Sep 2022
An estimate. Start dates often move.
- Expected to finish
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Nov 2024
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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