Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphocytic Leukemia

In brief

Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy for patients with hematologic malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphoblastic leukemia (ALL); however, human leukocyte antigen (HLA)-matched donor availability continues to be a major hurdle. Historically, HLA haploidentical donor hematopoietic cell transplantation (haplo-HCT) was associated with high incidences of graft rejection and excessive non-relapse mortality (NRM), but recent advances utilizing post-transplant cyclophosphamide (PT-Cy) have revolutionized haplo-HCT and the outcomes are now comparable to allo-HCT using more traditional HLA matched related and unrelated donors. However, graft-versus-host disease (GvHD) continues to be a problem and is associated with significant morbidity and mortality in allo-HCT patients including those who receive haplo-HCT on PT-Cy platform. The aim of this early phase study is to investigate the safety and overall efficacy of azacitidine in reducing the incidence and severity of GvHD when added to PT-Cy based haplo-HCT platform for patients with AML, ALL, or advanced MDS.

Key facts

Study ID: NCT02750254
Run by: Washington University School of Medicine
People needed: 5
Starts: 2016-06-27
Expected to finish: 2020-10-14
Last updated by the study team: 2020-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of acute leukemia (AML/ALL) or advanced MDS (INT-2 or high risk) in complete remission (CR/CRc/CRi) documented by bone marrow biopsy done within 30 days prior to the initiation of conditioning regimen.
Available HLA-haploidentical donor that meets the following criteria:
Immediate family member (sibling, offspring, or parent)
At least 18 years of age
HLA-haploidentical donor/recipient match by class I serologic typing at the A\&B locus.
In the treating physician's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting HSC
No active hepatitis (B, C), HTLV, and HIV infections
Not pregnant
Karnofsky performance status ≥ 70 %
Adequate organ function as defined below:
Total bilirubin ≤ 2.5 mg/dl (unless the patient has a history of Gilbert's syndrome)
AST(SGOT) and ALT(SGPT) ≤ 3.0 x IULN
Creatinine ≤ 2.0 x IULN OR estimated creatinine clearance ≥ 30 mL/min/1.73 m\^2 by Cockcroft-Gault Formula
Oxygen saturation ≥ 90% on room air
LVEF ≥ 40%
FEV1 and FVC ≥ 50% predicted, corrected DLCO ≥ 40% predicted
At least 18 years of age at the time of study registration
Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

You may not qualify if…

Recipients with donor sensitive antibodies (DSA), defined by 2000 or higher MFI against one or more class I or II antigens
Known HIV or active Hepatitis B or C infection
Underwent a previous related or unrelated allogeneic transplant
Known hypersensitivity to one or more of the study agents
Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of the conditioning regimen.
Pregnant and/or breastfeeding
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmias.
Presence of a readily available 6/6 matched sibling donor who is a candidate for donation

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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