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Cytokine
IFN-γ (interferon gamma-1b) injection for Myeloid Leukemia
Phase < 1
Waitlist Available
Led By Sawa Ito, MD; PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
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
- Myeloid Leukemia
- Myelodysplastic Syndrome
- Stem Cell Transplant
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events related to IFN-γ
Generation of phosphorylated-STAT1
Upregulation HLA l (HLA-ABC)
+2 moreSecondary outcome measures
Incidence of GVHD
Incidence of de novo GVHD
Malignant Blast Burden
Trial Design
1Treatment groups
Experimental Treatment
Group I: IFN-γExperimental Treatment1 Intervention
100mcg IFN-γ subcutaneously three times per week (Weeks 0-7), once per week (Weeks 8-12) (or per protocol guidance based on tolerability, response, or DLI infusions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IFN-γ (interferon gamma-1b) injection
2021
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,333 Total Patients Enrolled
Sawa Ito, MDLead Sponsor
Horizon Pharma USA, Inc.Industry Sponsor
22 Previous Clinical Trials
2,028 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are comfortable with giving samples of your bone marrow and blood as required by the study.You are allergic to interferon-gamma, E. coli derived products, or any component of the medication.You have a seizure disorder that is not managed well by medication.You have heart disease that is not under control with medication.
Research Study Groups:
This trial has the following groups:- Group 1: IFN-γ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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