Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | June 27, 2016 |
| End Date: | October 14, 2020 |
A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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