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OncoMatch/Clinical Trials/NCT05805605

Allo HSCT Using RIC and PTCy for Hematological Diseases

Is NCT05805605 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute myelogenous leukemia.

Phase 2RecruitingMasonic Cancer Center, University of MinnesotaNCT05805605Data as of May 2026

Treatment: Peripheral Blood Stem Cell Transplant · Allopurinol 300 MG · Fludarabine · Cyclophosphamide · Bone Marrow Cell Transplant · Sirolimus Pill · Mycophenolate MofetilThis is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Myelodysplastic Syndrome

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia

Myeloproliferative Neoplasm

Biomarker criteria

Required: NPM1 mutation

Normal karyotype with mutated NPM1 and wild type FLT-ITD

Required: FLT3 wild-type

Normal karyotype with mutated NPM1 and wild type FLT-ITD

Required: CEBPA double mutated

Normal karyotype with double mutated CEBPA

Required: IKZF1 alteration

Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1

Required: MLL rearrangement

other MLL rearrangements

Excluded: KIT mutation

t(8,21) without cKIT mutation

Allowed: BCR fusion

a positive PCR for BCRABL is acceptable for BMT

Allowed: ABL1 fusion

a positive PCR for BCRABL is acceptable for BMT

Prior therapy

Cannot have received: myeloablative transplant

Exception: at least 3 months since prior myeloablative transplant

Less than 3 months since prior myeloablative transplant

Lab requirements

Kidney function

A normal creatinine (adults) or creatinine clearance  40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated GFR  40 ml/min/1.73m2.

Liver function

Transaminases  5 x upper limit of normal (ULN) and total bilirubin  2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis.

Cardiac function

Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%.

Adequate organ function is defined as: Liver: Transaminases  5 x upper limit of normal (ULN) and total bilirubin  2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis. Renal: A normal creatinine (adults) or creatinine clearance  40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated GFR  40 ml/min/1.73m2. Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%. Pulmonary: DLCO, FEV1, FVC  40% predicted, and absence of O2 requirements.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Masonic Cancer Center at University of Minnesota · Minneapolis, Minnesota

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