RECRUITING

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Official Title

A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Quick Facts

Study Start:2024-10-11

Study Completion:2029-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06388564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥ 12 years of age at the time of informed consent. * New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy. * History of 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells). * Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L. * Willingness to avoid pregnancy or fathering children.	* Received more than 1 prior allo-SCT. Prior autologous HCT is allowed. * Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD. * Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis. * Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication. * Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1. * Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity. * Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse. * History of acute or chronic pancreatitis. * History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry. * Active symptomatic myositis. * Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible. * Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD. * Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization. * Pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells).
* Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L.
* Willingness to avoid pregnancy or fathering children.

* Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
* Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication.
* Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
* Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
* Active symptomatic myositis.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization.
* Pregnant or breastfeeding.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Mayo Clinic Hospital

Phoenix, Arizona, 85054

United States

City of Hope Medical Center

Duarte, California, 91010

United States

University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic

Los Angeles, California, 90095

United States

Stanford Cancer Center

Stanford, California, 94305

United States

University of Colorado Cancer Center

Aurora, Colorado, 80045

United States

Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

Smilow Cancer Center-Yale

New Haven, Connecticut, 06510

United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

United States

University of Miami Sylvester Comprehensive Cancer Center

Miami Springs, Florida, 33166

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

The University of Chicago Medicine

Chicago, Illinois, 60637

United States

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Washington University

Saint Louis, Missouri, 63110

United States

Fred and Pamela Buffett Cancer Center

Omaha, Nebraska, 68198

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

Weill Cornell Medicine

New York, New York, 10021

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43210

United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Md Anderson Cancer Center

Houston, Texas, 77030

United States

Seattle Children'S Hospital

Seattle, Washington, 98105

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11

Study Completion Date2029-12-01

Study Record Updates

Study Start Date2024-10-11

Study Completion Date2029-12-01

Terms related to this study

Keywords Provided by Researchers

cGVHD

Additional Relevant MeSH Terms

Chronic Graft-versus-host-disease