Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation

Summary

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

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHSCT

DRUG

Azacitidine

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Mycophenolate Mofetil

Given PO or IV

OTHER

Reduced-Intensity Transplant Conditioning Procedure

Undergo SOC RIC or NMA conditioning

DRUG

Ruxolitinib

Given PO

OTHER

Survey Administration

Ancillary studies

DRUG

Tacrolimus

Given PO or IV

Sponsors & Collaborators

• Incyte Corporation

  collaborator INDUSTRY

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Jennifer N Saultz · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-20

Primary Completion

2027-12-31

Completion

2028-12-29

FDA Drug

Yes

Countries

• United States

Study Locations