Acute Myeloid Leukemia Clinical Trial

Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT02750254

Recruitment Status:

Terminated

Sponsor:

Washington University School of Medicine

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Washington University School of Medicine
Saint Louis Missouri, 63110, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT02750254

Recruitment Status:

Terminated

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider