Study Summary
This trial will test if IFN-γ can help people with AML/MDS that has relapsed after alloSCT by promoting graft-vs-leukemia (GVL).
Eligible Conditions
- Allogeneic Stem Cell Transplant
- Myeloid Leukemia
- Myelodysplastic Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Phase < 1
Study Objectives
5 Primary · 3 Secondary · Reporting Duration: Up to 6 months
Up to 6 months
Adverse events related to IFN-γ
Generation of phosphorylated-STAT1
Incidence of GVHD
Incidence of de novo GVHD
Malignant Blast Burden
Upregulation HLA l (HLA-ABC)
Upregulation of HLA ll (HLA-DR/DQ)
Upregulation of ICAM-1
Trial Safety
Phase-Based Safety
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
IFN-γ
1 of 1
Experimental Treatment
6 Total Participants · 1 Treatment Group
Primary Treatment: IFN-γ (interferon gamma-1b) injection · No Placebo Group · Phase < 1
IFN-γ
Drug
Experimental Group · 1 Intervention: IFN-γ (interferon gamma-1b) injection · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,646 Previous Clinical Trials
16,311,501 Total Patients Enrolled
Sawa Ito, MDLead Sponsor
Horizon Pharma USA, Inc.Industry Sponsor
21 Previous Clinical Trials
1,948 Total Patients Enrolled
Sawa Ito, MD; PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are comfortable with giving samples of your bone marrow and blood as required by the study.