RecruitingPhase 2

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 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests interferon-gamma (IFN-γ) with an infusion of donor white blood cells to see how well it works and how safe it is. It is for adults whose acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) came back after a donor stem cell transplant.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older.
  • You must have had a donor stem cell transplant for AML or MDS. The donor must match at least 8 of 8 tissue markers, or be a partly matched donor matching at least 4 of 8.
  • Tests must show that AML or MDS has returned. Bone marrow, cell, chromosome, or gene tests must meet the study’s limits; abnormal early blood cells must not exceed 30%.
  • You must be able to care for yourself and be out of bed for at least half of your waking hours.
  • Donor white blood cells must be available, or your donor must agree to have them collected.
  • You may have had no more than one course of treatment for the relapse. Most drugs require a break of more than 2 weeks; research drugs require at least 4 weeks or longer, depending on how long they stay in the body.
  • You must sign a consent form and agree to all study steps and visits.
  • Women under 55 without documented menopause or surgery to remove the womb or ovaries must use two birth control methods, including one highly effective method. Men must use condoms, and their female partners must use highly effective birth control during the study.

Who can't join

  • Your donor stem cells never started making blood cells. For the fully matched donor group, leukemia with a mix of myeloid and lymphoid cell types also rules you out.
  • You have severe acute or moderate-to-severe chronic graft-versus-host disease, where donor cells attack your body; had the most severe acute form before; or took medicines that suppress the immune system throughout the body within 2 weeks.
  • You still have severe side effects from earlier treatment that affect parts of the body other than the blood, or you cannot receive IFN-γ because of an allergy or another medical reason.
  • You have a positive pregnancy test or are breastfeeding on the first treatment day.
  • You have certain recent heart problems, including an uncontrolled abnormal heartbeat, heart failure, or poor blood flow to the heart. Some heart failure caused by a now-controlled fast heartbeat may be allowed.
  • You need oxygen all the time for lung disease, or had seizures not controlled by medicine within 2 months.
  • Your liver tests are too high: AST or ALT over 5 times the normal limit, or bilirubin over 3 times the normal limit. Kidney filtering below 30 mL/min also rules you out.
  • For the partly matched donor group, tests within 30 days show that the returned cancer cells lost the tissue markers that did not match the donor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. 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) 3. AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria: 1. At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36 2. 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. 3. Recurrent or persistent cytogenetic abnormalities detectable by FISH or karyotype analysis. 4. 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 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 5. A DLI is available, or the donor is available and agrees to undergo apheresis to collect lymphocytes for infusion 6. If salvage therapy for post-alloSCT relapse was received, the therapy is limited to 1 line of the following: 1. 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 2. For cytotoxic chemotherapy agents, the last dose must be \>2 weeks prior to start of treatment for the present study 3. 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 7. Provision of signed and dated informed consent form 8. Stated willingness to comply with all study procedures and availability for the duration of the study 9. 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 10. 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 Exclusion Criteria: 1. Primary engraftment failure after alloSCT 2. Evidence of mixed phenotype leukemia with lymphoid differentiation (Cohort 1: HLA -matched alloSCT recipients) 3. Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment 4. History of grade 4 aGVHD per the MAGIC criteria 5. Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment 6. Any systemic immunosuppressive medications taken within 2 weeks before the enrollment 7. Grade 3 or higher non-hematologic toxicity related to any prior therapy at the time of enrollment 8. A contraindication to receive IFN-γ including a known hypersensitivity to IFN-γ, E. coli derived products or any other component of the product 9. Positive pregnancy test or currently breastfeeding on Day 1 of study treatment 37 10. 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 11. Active ischemic heart disease not controlled with medications within 2 months of enrollment 12. Acute or chronic pulmonary disease requiring continuous oxygen treatment 13. Seizure disorder not controlled by medications within 2 months of enrollment 14. AST or ALT \> 5x ULN or total bilirubin \>3x ULN at time of enrollment 15. Renal function CrCl \<30 mL/min at time of enrollment using modified Cockcroft-Gault formula 16. 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)

Study sites (3)

MO

PA

WA