OncoMatch/Clinical Trials/NCT03314974
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
Is NCT03314974 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including HSCT with TBI Regimen and HSCT with Non-TBI Regimen for acute leukemia.
Treatment: HSCT with TBI Regimen · HSCT with Non-TBI Regimen — This 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia
Multiple Myeloma
Myeloproliferative Neoplasm
Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
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
Demographics
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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See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03314974 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior myeloablative transplant disqualifies patients from enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 wild-type is a required biomarker for enrollment.
Does this trial require CEBPA?
Yes, CEBPA double mutated is a required biomarker for enrollment.
Are patients with KIT alterations eligible?
No. KIT mutation is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 60 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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