Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529731
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Interferon-γ IFN-γ With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This novel regimen has the potential to fill a large unmet need for this high-risk population of patients who have few if any effective therapeutic options If this trial confirms the clinical efficacy of IFN-γDLI it will establish a new standard of care for post-transplant AMLMDS relapse It would also provide a rationale to explore other indications for IFN-γ in the context of an alloSCT including 1 IFN-γDLI for relapsed disease after haploidentical alloSCT 2 pre-emptive post-alloSCT treatment of patients transplanted with measurable residual disease MRD or with poor-risk AMLMDS such as with TP53 mutations and 3 prevention of relapse in patients who can only tolerate reduced-intensity conditioning regimens which in most studies results in higher rates of post-alloSCT AMLMDS relapse than when intensive conditioning regimens are employed Together this work would allow more patients with AMLMDS to be referred for and ultimately benefit from an alloSCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None