Phase 1 Ruxolitinib, Azacitidine Maintenance for AML Undergoing Allogeneic Stem Cell Transplantation
ClinicalTrials.gov Studies
Summary
Phase 1 clinical trial NCT07548983 evaluates ruxolitinib monotherapy followed by ruxolitinib plus azacitidine maintenance in acute myeloid leukemia patients undergoing reduced intensity allogeneic hematopoietic stem cell transplantation. The trial aims to assess safety, tolerability, and efficacy while examining whether ruxolitinib can prevent graft-versus-host disease and azacitidine maintenance can delay cancer recurrence. Registered April 23, 2026, the study involves multiple interventions including stem cell transplantation, immunosuppressants, and surveillance procedures.
“Ruxolitinib is in a class of medications called kinase inhibitors.”
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What changed
This clinical trial registration documents a Phase 1 study evaluating ruxolitinib therapy alone followed by ruxolitinib combined with azacitidine maintenance in AML patients undergoing reduced intensity allogeneic stem cell transplantation. Ruxolitinib works by blocking signals of cells causing graft-versus-host disease, while azacitidine helps the bone marrow produce normal blood cells and kills abnormal cells. The trial includes multiple interventions such as cyclophosphamide, tacrolimus, mycophenolate mofetil, and various monitoring procedures including bone marrow biopsies and cardiac imaging.
Healthcare providers treating AML patients should note this trial evaluates a novel combination approach targeting both GVHD prevention and cancer recurrence. Clinical investigators may identify eligible patients for referral, while pharmaceutical manufacturers of these generic agents may observe emerging evidence for combination maintenance therapy in transplant settings.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation
Phase 1 NCT07548983 Kind: PHASE1 Apr 23, 2026
Abstract
This phase I trial studies the side effects and best dose of ruxolitinib (Rux) therapy alone (monotherapy) followed by Rux plus azacitidine (AZA) maintenance therapy and to see how well it works in treating patients with acute myeloid leukemia (AML) who are undergoing reduced intensity allogeneic hematopoietic stem cell transplantation (alloHSCT). AlloHSCT provides the only chance for cure for many patients with AML. AlloHSCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. One of the common reasons for death after an alloHSCT is graft versus host disease (GVHD), which occurs when the transplanted cells from the donor attacks the recipient's normal cells. Ruxolitinib is in a class of medications called kinase inhibitors. It works to treat GVHD by blocking the signals of the cells that cause GVHD. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Giving Rux after the transplant may stop GVHD from occurring. Maintenance therapy with AZA, may help prevent or delay cancer from coming back. Giving Rux monotherapy followed by Rux plus AZA maintenance therapy may be safe, tolerable, and/or effective in treating patients with AML who are undergoing alloHSCT.
Conditions: Acute Myeloid Leukemia
Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cyclophosphamide, Echocardiography Test, Electronic Health Record Review, Multigated Acquisition Scan, Mycophenolate Mofetil, Reduced-Intensity Transplant Conditioning Procedure, Ruxolitinib, Survey Administration, Tacrolimus
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