IFN-γ (interferon gamma-1b) injection for Stem Cell Transplant

Fred Hutchinson Cancer Research Center, Seattle, WA
Stem Cell Transplant+2 More ConditionsIFN-γ (interferon gamma-1b) injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Drug

Trial 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.