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New treatment option for Acute Myeloid Leukemia
Official title Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06529731
What this study is testing
What is Interferon gamma-1b?
Interferon gamma-1b is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ACTIMMUNE®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and 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 test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor
- 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...
You likely can't join if
- Primary engraftment failure after alloSCT
- 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
- Grade 3 or higher non-hematologic toxicity related to any prior therapy at the time of enrollment
See the full eligibility criteria
- Age ≥ 18 years
- Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor
- 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.
- 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...
- 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...
- Primary engraftment failure after alloSCT
- 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
- 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...
- 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
- Body surface area ≤ 1.5 m2 or ≥ 2.5 m2 so as to minimize variation in IFN-γ exposure based on differences in body surface area
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Pittsburgh, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.