Trials / Terminated
TerminatedNCT02750254
Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | |
| RADIATION | Fractionated total body irradiation | |
| DRUG | Busulfan | |
| DRUG | Cyclophosphamide | |
| RADIATION | Single dose total body irradiation | |
| DRUG | Melphalan | |
| DRUG | Granulocyte-colony stimulating factor | |
| PROCEDURE | Stem cell transplant | |
| DRUG | Azacitidine |
Timeline
- Start date
- 2016-06-27
- Primary completion
- 2017-05-24
- Completion
- 2020-10-14
- First posted
- 2016-04-25
- Last updated
- 2020-10-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02750254. Inclusion in this directory is not an endorsement.