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OncoMatch/Clinical Trials/NCT03314974

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Is NCT03314974 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HSCT with TBI Regimen and HSCT with Non-TBI Regimen for acute leukemia.

Phase 2RecruitingMasonic Cancer Center, University of MinnesotaNCT03314974Data as of May 2026

Treatment: HSCT with TBI Regimen · HSCT with Non-TBI RegimenThis is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Chronic Myeloid Leukemia

Myeloproliferative Neoplasm

Chronic Lymphocytic Leukemia

Multiple Myeloma

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: MLL rearrangement

other MLL rearrangements

Required: IKZF1 mutation

IKZF1

Excluded: KIT mutation

t(8,21) without cKIT mutation; inv(16) or t(16;16) without cKIT mutation

Prior therapy

Must have received: tyrosine kinase inhibitor — Chronic Myelogenous Leukemia, first chronic phase (CP1)

To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.

Must have received: initial therapy — Plasma Cell Leukemia

Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission

Must have received: initial therapy — Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia

Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.

Cannot have received: myeloablative transplant

Exception: if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant

if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant

Lab requirements

Kidney function

Creatinine <2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2

Liver function

Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal

Cardiac function

Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation

Adequate Organ Function: Renal: Creatinine <2x upper limit of normal... Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal... Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%...

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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