OncoMatch/Clinical Trials/NCT05805605
Allo HSCT Using RIC and PTCy for Hematological Diseases
Is NCT05805605 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for acute myelogenous leukemia.
Treatment: Peripheral Blood Stem Cell Transplant · Allopurinol 300 MG · Fludarabine · Cyclophosphamide · Bone Marrow Cell Transplant · Sirolimus Pill · Mycophenolate Mofetil — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia
Multiple Myeloma
Myelodysplastic Syndrome
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05805605 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 75 years or younger and at least 0 years old.
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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