Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Masonic Cancer Center, University of Minnesota1 site in 1 country56 target enrollmentMay 1, 2023

Overview

Phase: Phase 2
Intervention: Peripheral Blood Stem Cell Transplant
Conditions: Acute Myelogenous Leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Enrollment: 56
Locations: 1
Primary Endpoint: Evaluate rates of chronic graft-versus-host disease (GVHD)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

October 22, 2028

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masonic Cancer Center, University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years).
•5/6 or 6/6 related donor, OR a 7-8/8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5/10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.
•Eligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.
•Acute Myeloid Leukemia (AML) and related precursor neoplasms:
•2nd or greater complete remission (CR); first complete remission (CR1) in patients \> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.
•Favorable risk AML is defined as having one of the following:
•t(8,21) without cKIT mutation
•inv(16) or t(16;16) without cKIT mutation
•Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)
•Normal karyotype with double mutated CEBPA

Exclusion Criteria

•Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
•Untreated active infection
•Active central nervous system malignancy
•CML in blast crisis
•Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
•Less than 3 months since prior myeloablative transplant
•Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.