NCT01390311

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

A Phase I Study of the Safety and Feasibility of Azacitidine After Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome After Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.

Detailed description

PRIMARY OBJECTIVES: -To determine the Maximum Tolerated Dose (MTD) of 5-AzaC (azacitidine) when given after chemotherapy and DLI in patients with AML/MDS who relapse after allogeneic stem cell transplant. SECONDARY OBJECTIVES: * To determine the rate of Grades II-IV and III-IV acute GVHD (aGVHD) in first 100 days after DLI. * To determine the rates of complete remission (CR), partial remission, (PR) and complete remission with incomplete count recovery (CRi), and overall response rate (CR+ CRi + PR). * To determine overall survival 100 days after DLI. * To determine the effects of increasing dose of 5-AzaC on frequency and absolute number of resting regulatory T-cells (rTregs) and activated Tregs (aTregs) at baseline, 7 days, 14 days, 21 days, and \~60 days after first dose of 5-AzaC.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Azacitidine
DRUG	Pre-DLI Salvage Chemotherapy	At the discretion of the treating physician
BIOLOGICAL	Donor Leukocyte Infusion (DLI)

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-03-01
• Completion: 2015-04-01
• First posted: 2011-07-11
• Last updated: 2015-04-27

Locations

1 site across 1 country: United States