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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT07548983
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo alloHSCT
  • Azacitidine — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Mycophenolate Mofetil — DRUG
    Given PO or IV
  • Reduced-Intensity Transplant Conditioning Procedure — OTHER
    Undergo SOC RIC or NMA conditioning
  • Ruxolitinib — DRUG
    Given PO
  • Survey Administration — OTHER
    Ancillary studies
  • Tacrolimus — DRUG
    Given PO or IV

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 29, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib, azacitidine)
    See Detailed Description.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: From cycle 1 day 1 (day +5 post-transplant) to end of cycle 2 (Cycle length = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Jennifer N. Saultz
[email protected]
503-494-5566
Jennifer N. Saultz (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
OHSU Knight Cancer Institute· Portland, OR

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