Acute Myeloid LeukemiaPhase 2NCT06529731
Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Interferon gamma-1b and Donor Leukocyte Infusion (DLI) in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Sawa Ito, MD at 3 sites in United States.
Trial summary
This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Interferon gamma-1b and Donor Leukocyte Infusion (DLI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Sep 2024to 31 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor (Cohort 1: HLA -matched alloSCT recipients) or recipients of a haploidentical donor SCT for AML or MDS from a minimally 4/8 HLA-matched donor (Cohort 2: Haplo-SCT recipients)
- AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria:
- At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36
- At least 0.1% of abnormal myeloblasts with a leukemia-associated immunophenotype (LAIP) by multiparameter flow cytometry. The abnormal cells with LAIP should not exceed 30% of nucleated cells.
- Recurrent or persistent cytogenetic abnormalities detectable by FISH or karyotype analysis.
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- For patients with mutant NPM1, at least 1,000 mutant transcript copies per 106 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- A DLI is available, or the donor is available and agrees to undergo apheresis to collect lymphocytes for infusion
- If salvage therapy for post-alloSCT relapse was received, the therapy is limited to 1 line of the following:
- For hypomethylating agents, venetoclax, and targeted therapies (e.g., tyrosine kinase inhibitors, IDH1/IDH2 inhibitors, or FLT3 inhibitors), the last dose must be > 2 week prior to the initiation of IFN-γ
- For cytotoxic chemotherapy agents, the last dose must be >2 weeks prior to start of treatment for the present study
- For investigational agents, the last dose must be ≥ 4 weeks or 5 half-lives (whichever is longer) prior to the start of treatment for the present study
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- For female subject, who is < 55 years old without hysterectomy, oophorectomy or documented menopause, willingness to use two forms of contraception including one form of highly effective contraception (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study
- For male subject, willingness to use highly effective contraception methods including male condoms by male subject and one form of highly effective contraception by his female partner (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study
Who cannot join
- Primary engraftment failure after alloSCT
- Evidence of mixed phenotype leukemia with lymphoid differentiation (Cohort 1: HLA -matched alloSCT recipients)
- Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment
- History of grade 4 aGVHD per the MAGIC criteria
- Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment
- Any systemic immunosuppressive medications taken within 2 weeks before the enrollment
Show all 16Show fewer
- Grade 3 or higher non-hematologic toxicity related to any prior therapy at the time of enrollment
- A contraindication to receive IFN-γ including a known hypersensitivity to IFN-γ, E. coli derived products or any other component of the product
- Positive pregnancy test or currently breastfeeding on Day 1 of study treatment 37
- Active cardiac arrhythmia not controlled by medical management or current NYHA class II or higher congestive heart failure within 2 months of enrollment unless it was due to a tachyarrhythmia which is under control at the time of enrollment
- Active ischemic heart disease not controlled with medications within 2 months of enrollment
- Acute or chronic pulmonary disease requiring continuous oxygen treatment
- Seizure disorder not controlled by medications within 2 months of enrollment
- AST or ALT > 5x ULN or total bilirubin >3x ULN at time of enrollment
- Renal function CrCl <30 mL/min at time of enrollment using modified Cockcroft-Gault formula
- Detection of HLA loss of heterozygosity (LOH) in relapsed malignant cells. Specifically, there has been a loss of the mismatched set of HLA alleles encoded on chromosome 6 (ie uniparental disomy of chromosome 6), within 30 days prior to enrollment (Cohort 2: Haplo-SCT recipients)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Linda Elias, RN, 412-623-6037, eliaslj@upmc.edu
Amy Rodger, RN, 412-623-4036, rodgax@upmc.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Elizabeth Frecker, B.S., SMB-A, 206-667-4129, efrecker@fredhutch.org
Alisa Bradford, 206-667-2834, ajbradfo@fredhutch.org
- Recruiting
Washington University
St Louis, Missouri, 63110
Ayan Gasanli, MBA, 314-747-2449, agasanli@wustl.edu
Ryan Monahan, MBA, 314-454-8377, rmonahan@wustl.edu
About this study
Official title: A Phase 2 Trial of Interferon-γ (IFN-γ) in Combination With Donor Leukocyte Infusion (DLI) to Treat Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) After Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will further contribute to this effort through the collection of leukemia cells pre- and post-in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Read the detailed description
This novel regimen has the potential to address a significant unmet need for this high-risk population of patients who have few, if any, effective therapeutic options. In Cohort 1, if this trial confirms the clinical efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after HLA-matched alloSCT, it may establish a new therapeutic approach for post-transplant AML/MDS relapse. Cohort 2 will further evaluate the safety and potential efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after haploidentical alloSCT, where treatment options are also limited and the risk of GVHD requires careful assessment. Together, these cohorts would provide a rationale to explore additional indications for IFN-γ in the context of alloSCT, including 1) IFN-γ/DLI for relapsed disease after haploidentical alloSCT; 2) pre-emptive post-alloSCT treatment of patients transplanted with measurable residual disease (MRD) or with poor-risk AML/MDS, such as disease with TP53 mutations; and 3) prevention of relapse in patients who can only tolerate reduced-intensity conditioning regimens, which in most studies are associated with higher rates of post-alloSCT AML/MDS relapse than intensive conditioning regimens. Collectively, this work may allow more patients with AML/MDS to be referred for and ultimately benefit from alloSCT.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Interferon gamma-1b, Donor Leukocyte Infusion (DLI)
- Keywords
- interferon-γ (IFN-γ), donor leukocyte infusion (DLI), allogeneic hematopoietic stem cell transplantation (alloSCT)
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma-1bDrug
Also called ACTIMMUNE®
ACTIMMUNE/Interferon gamma-1b is a single-chain polypeptide containing 140 amino acids that is produced by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein. Interferon gamma-1b is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively.
Donor Leukocyte Infusion (DLI)Biological
Donor lymphocyte infusion is a procedure that transfers healthy white blood cells (lymphocytes) from a bone marrow or stem cell donor to a recipient's blood. An infusion of healthy lymphocytes helps the recipient's immune system get rid of remaining cancer cells if they have a relapse after a bone marrow or stem cell transplant for blood cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: IFN-γ + DLI (HLA-matched donor alloSCT recipient cohort) | Experimental | 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) Receives: Drug: Interferon gamma-1b; Biological: Donor Leukocyte Infusion (DLI) |
| Cohort 2: IFN-γ + DLI (Haploidentical donor alloSCT recipient cohort) | Experimental | 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 1st dose of 10^6 CD3+ cells/kg, 2nd dose 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) Receives: Drug: Interferon gamma-1b; Biological: Donor Leukocyte Infusion (DLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Cohort 1: Occurrence of treatment failure, hematologic relapse from a CR (complete remission)/CRh/Cri), or death observed from start of IFN-γ treatment. Patients alive at 1 year after start of treatment will be censored on the date of last contact.
Measured: At 1 year
Incidence of steroid- and ruxolitinib- refractory GVHD within 12 weeks after the first dose of IFN-γ
Cohort 2: Lack of improvement after 7 days of methylprednisolone 2 mg/kg, AND, either of the following
- Progression of graft-vs-host disease (GVHD) compared with baseline after 10 days of ruxolitinib, based either on an objective increase in stage/grade or new organ involvement Or
- Lack of improvement in GVHD (PR or better) compared with baseline after at least 14 days of ruxolitinib.
Measured: 12 Weeks
Secondary outcomes (11)
Event-free survival (EFS) - Landmark 1-year
Time from start of IFN-γ treatment until event of death, date of treatment failure, or hematologic relapse from a CR/CRh/Cri. CR is defined by blasts less than 5% by morphology defined by bone marrow blasts less than 5%; absence of circulating blasts; absence of extramedullary disease; absolute neutrophil count (ANC) at or greater than 1,000/mL; platelet count at or greater than 100,000/mL CRh is defined by ANC at or greater than 500/mL and platelet count at or greater than 50,000/mL otherwise all other CR criteria met. CRi is defined by all CR criteria except for residual neutropenia less than 1,000/mL or thrombocytopenia less than 100,000/mL Treatment failure is not achieving either CR, CRh or CRi by 6 months. Patients evaluable for response without CR, CRh or CRi by 6 months and patients who die before 6 months without response assessments are considered an event at day 1 of IFN-γ treatment
Measured: Up to 1 year
Minimal residual disease (MRD)
Rate of complete remission (CR) with no measurable disease at 6 months. CR is defined as
Measured: At 6 months
Complete Remission (CR)
Proportion of patients who experience Complete Remission (CR). CR is defined by bone marrow blasts less than 5%; absence of circulating blasts; absence of extramedullary disease; absolute neutrophil count (ANC) at or greater than 1,000/mL; platelet count at or greater than 100,000/mL. The proportion of responders will be calculated as the number of responders divided by the number of evaluable patients.
Measured: At 6 months
Complete remission with partial hematologic recovery (CRh)
Proportion of patients who experience Complete remission with partial hematologic recovery (CRh). CRh is defined by ANC at or greater than 500/mL and platelet count at or greater than 50,000/mL otherwise all other CR criteria met. The proportion of responders will be calculated as the number of responders divided by the number of evaluable patients.
Measured: At 6 months
Complete remission with incomplete count recovery (CRi)
Proportion of patients who experience complete remission with incomplete count recovery (CRi). CRi is defined by all CR criteria except for residual neutropenia less than 1,000/mL or thrombocytopenia less than 100,000/mL51. The proportion of responders (CR, CRh, or CRi) will be calculated as the number of responders divided by the number of evaluable patients. The proportion of responders will be calculated as the number of responders divided by the number of evaluable patients.
Measured: At 6 months
Overall survival
Time from start of IFN-γ to death by any cause or censored on the date of last contact.
Measured: Up to 1 year
Rate of donor chimerism
Proportion of the efficacy population with ≥95% peripheral blood CD3+ and CD33+ cells and of unfractionated bone marrow being donor-derived
Measured: At 6 months
Rate of transfusion independence
Proportion of the subjects who achieve the absence of a red-cell or platelet transfusion for at least 56 days between the first and last day of treatment.
Measured: At 1 year
Frequency and severity of adverse events (AEs)
Number of patients who experience an Adverse Event or Serious Adverse Event related to study treatment, per CTCAE v5.0 criteria. Distinct number of patients will be determined per each event type by highest grade experienced.
Measured: Up to 6 months
Frequency of new onset grade 3 or 4 acute graft-versus-host disease (aGVHD)
number of patients meeting criteria for grade 3 or 4 aGVHD per MAGIC divided by the number of evaluable patients. The MAGIC criteria as follows: Overall clinical grade (based on most severe target organ involvement): Grade 0: No stage 1-4 of any organ; Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement; Grade II: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI; Grade Ill: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI; Grade IV: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI.
Measured: Up to 12 months
Frequency of new onset moderate or severe chronic GVDH (cGVHD)
The number of patients meeting criteria for moderate or severe cGVHD per NIH Consensus Criteria divided by the number of evaluable patients. The NIH Consensus Criteria is a diagnostic assessment that evaluates hair, skin, nails, eyes, mouth, genitalia, GI tract, liver, lung, muscles and joints, hematopoietic and immune system, cardiac and neurological condition/function, to determine whether or not the GVHD is chronic.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start23 Sep 2024
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sawa Ito, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Evans MDS Discovery Research Grant, Amgen, FDA Office of Orphan Products Development
- Responsible party
- Sponsor-investigator, Sawa Ito, MD, University of Pittsburgh
- Investigators
- Sawa M Ito, MD, PhD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529731
- Sponsor's protocol ID
- HCC 23-160
- Other IDs
- 1R01FD008187-01
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Interferon-γ (IFN-γ) in Combination With Donor Leukocyte Infusion (DLI) to Treat Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) After Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
- ClinicalTrials.gov ID
- NCT06529731
- Acronym / sponsor ID
- HCC 23-160
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- interferon-γ (IFN-γ), donor leukocyte infusion (DLI), allogeneic hematopoietic stem cell transplantation (alloSCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Sawa Ito, MDUniversity, hospital or other
- Collaborators
- Evans MDS Discovery Research Grant, Amgen, FDA Office of Orphan Products Development
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will further contribute to this effort through the collection of leukemia cells pre- and post-in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Detailed description
This novel regimen has the potential to address a significant unmet need for this high-risk population of patients who have few, if any, effective therapeutic options. In Cohort 1, if this trial confirms the clinical efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after HLA-matched alloSCT, it may establish a new therapeutic approach for post-transplant AML/MDS relapse. Cohort 2 will further evaluate the safety and potential efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after haploidentical alloSCT, where treatment options are also limited and the risk of GVHD requires careful assessment. Together, these cohorts would provide a rationale to explore additional indications for IFN-γ in the context of alloSCT, including 1) IFN-γ/DLI for relapsed disease after haploidentical alloSCT; 2) pre-emptive post-alloSCT treatment of patients transplanted with measurable residual disease (MRD) or with poor-risk AML/MDS, such as disease with TP53 mutations; and 3) prevention of relapse in patients who can only tolerate reduced-intensity conditioning regimens, which in most studies are associated with higher rates of post-alloSCT AML/MDS relapse than intensive conditioning regimens. Collectively, this work may allow more patients with AML/MDS to be referred for and ultimately benefit from alloSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: IFN-γ + DLI (HLA-matched donor alloSCT recipient cohort) | Experimental | Drug: Interferon gamma-1b, Biological: Donor Leukocyte Infusion (DLI)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) |
| Cohort 2: IFN-γ + DLI (Haploidentical donor alloSCT recipient cohort) | Experimental | Drug: Interferon gamma-1b, Biological: Donor Leukocyte Infusion (DLI)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 1st dose of 10^6 CD3+ cells/kg, 2nd dose 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor (Cohort 1: HLA -matched alloSCT recipients) or recipients of a haploidentical donor SCT for AML or MDS from a minimally 4/8 HLA-matched donor (Cohort 2: Haplo-SCT recipients)
- AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- A DLI is available, or the donor is available and agrees to undergo apheresis to collect lymphocytes for infusion
Key exclusion criteria (16 listed)
- Primary engraftment failure after alloSCT
- Evidence of mixed phenotype leukemia with lymphoid differentiation (Cohort 1: HLA -matched alloSCT recipients)
- Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment
- History of grade 4 aGVHD per the MAGIC criteria
- Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon gamma-1bAlso: ACTIMMUNE®ACTIMMUNE/Interferon gamma-1b is a single-chain polypeptide containing 140 amino acids that is produced by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein. Interferon gamma-1b is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively. | Drug | Cohort 1: IFN-γ + DLI (HLA-matched donor alloSCT recipient cohort), Cohort 2: IFN-γ + DLI (Haploidentical donor alloSCT recipient cohort) |
| Donor Leukocyte Infusion (DLI)Donor lymphocyte infusion is a procedure that transfers healthy white blood cells (lymphocytes) from a bone marrow or stem cell donor to a recipient's blood. An infusion of healthy lymphocytes helps the recipient's immune system get rid of remaining cancer cells if they have a relapse after a bone marrow or stem cell transplant for blood cancer. | Biological | Cohort 1: IFN-γ + DLI (HLA-matched donor alloSCT recipient cohort), Cohort 2: IFN-γ + DLI (Haploidentical donor alloSCT recipient cohort) |
Primary outcome
Event-free survival (EFS)
Time frame: At 1 year
Cohort 1: Occurrence of treatment failure, hematologic relapse from a CR (complete remission)/CRh/Cri), or death observed from start of IFN-γ treatment. Patients alive at 1 year after start of treatment will be censored on the date of last contact.
Incidence of steroid- and ruxolitinib- refractory GVHD within 12 weeks after the first dose of IFN-γ
Time frame: 12 Weeks
Cohort 2: Lack of improvement after 7 days of methylprednisolone 2 mg/kg, AND, either of the following 1. Progression of graft-vs-host disease (GVHD) compared with baseline after 10 days of ruxolitinib, based either on an objective increase in stage/grade or new organ involvement Or 2. Lack of improvement in GVHD (PR or better) compared with baseline after at least 14 days of ruxolitinib.
11 secondary outcomes
Event-free survival (EFS) - Landmark 1-year
Time frame: Up to 1 year
Minimal residual disease (MRD)
Time frame: At 6 months
Complete Remission (CR)
Time frame: At 6 months
Complete remission with partial hematologic recovery (CRh)
Time frame: At 6 months
Complete remission with incomplete count recovery (CRi)
Time frame: At 6 months
Overall survival
Time frame: Up to 1 year
Rate of donor chimerism
Time frame: At 6 months
Rate of transfusion independence
Time frame: At 1 year
Frequency and severity of adverse events (AEs)
Time frame: Up to 6 months
Frequency of new onset grade 3 or 4 acute graft-versus-host disease (aGVHD)
Time frame: Up to 12 months
Frequency of new onset moderate or severe chronic GVDH (cGVHD)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sawa M Ito, MD, PhD principal investigator
UPMC Hillman Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon gamma-1b and Donor Leukocyte Infusion (DLI) in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Sawa Ito, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Elias, RN (412-623-6037, eliaslj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: At 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.