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Cytokine Therapy

IFN-γ + Donor Leukocyte Infusion for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Sawa M Ito, MD, PhD

Research Sponsored by Sawa Ito, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recipients of an alloSCT for AML or MDS from an HLA-matched donor

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

Must not have

Primary engraftment failure after alloSCT

Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to build on previous research by testing the effectiveness of IFN-γ therapy on leukemia cells. They will collect leukemia cells before and after treatment to see how they respond to IFN-

Who is the study for?

This trial is for individuals who have relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes after a stem cell transplant. Participants must have had leukemia cells that previously responded to IFN-γ in tests.

What is being tested?

The study is testing the effectiveness of Interferon gamma-1b combined with Donor Leukocyte Infusion (DLI) on patients. It's a phase 2 trial building on earlier positive results, and includes detailed analysis of how leukemia cells react to treatment.

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood counts leading to increased infection risk, and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I received a stem cell transplant for AML or MDS from a donor who was an HLA match.

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I am able to care for myself and perform daily activities.

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My AML/MDS has returned after a stem cell transplant, with 5-30% cancer cells in my bone marrow.

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I have a donor ready for lymphocyte donation.

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I am a woman under 55 and agree to use two forms of birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My bone marrow transplant didn't work as expected.

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I have severe acute GVHD according to the MAGIC criteria.

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I have had a severe reaction to a stem cell transplant.

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I have moderate or severe chronic graft-versus-host disease.

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I have not taken any immunosuppressive medications in the last 2 weeks.

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I have severe side effects from previous treatments.

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I am allergic to IFN-γ or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Secondary study objectives

Complete Remission (CR)

Complete remission with incomplete count recovery (CRi)

Complete remission with partial hematologic recovery (CRh)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IFN-γ + DLIExperimental Treatment2 Interventions

ACTIMMUNE® (IFN-γ-1b) at a dose of 50 mcg/m\^2 (All participants will receive a 4-week period of IFN-γ monotherapy with ACTIMMUNE 100 mcg 3 times a week. This dose and schedule will be continued for 4 additional weeks and then tapered to 100 mcg weekly for an additional 4 weeks) DLI at a dose of 10\^7 CD3+ cells/kg (DLI doses will be given pending clinical assessment for disease, graft versus host disease (GVHD) and peripheral blood donor chimerism the week prior to DLI. Second DLI dose is only offered to subjects with residual disease not requiring cytotoxic therapy and without GVHD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interferon gamma-1b

2016

Completed Phase 2

~10

Donor Leukocyte Infusion (DLI)

2012

Completed Phase 1

~20