RECRUITING

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Conditions

Chronic Graft-versus-host Disease (cGVHD)

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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

Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.

Official Title

Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy

Quick Facts

Study Start:2024-11-21

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06660355

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years. * Karnofsky performance status ≥60%. * Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed. * No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment. * Able to take oral medications. * Participants must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥30,000/mcL 3. Hemoglobin ≥ 7 g/dL 4. Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration. * Ability to understand and the willingness to sign a written informed consent document.	* Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD). * Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded. * Relapse malignancy post- transplant. * Active hepatitis B, hepatitis C and HIV will be excluded. * Any uncontrolled infection at the time if enrollment will be excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib. * Current or history of active Tuberculosis.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years.
* Karnofsky performance status ≥60%.
* Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed.
* No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.
* Able to take oral medications.
* Participants must have adequate organ and marrow function as defined below:
1. absolute neutrophil count ≥1,000/mcL
2. platelets ≥30,000/mcL
3. Hemoglobin ≥ 7 g/dL
4. Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.
* Ability to understand and the willingness to sign a written informed consent document.

* Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD).
* Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded.
* Relapse malignancy post- transplant.
* Active hepatitis B, hepatitis C and HIV will be excluded.
* Any uncontrolled infection at the time if enrollment will be excluded.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib.
* Current or history of active Tuberculosis.

Contacts and Locations

Study Contact

Jo Hill

CONTACT

813-745-4651

jo.hill@moffitt.org

Principal Investigator

Farhad Khimani, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Farhad Khimani, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

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 Date2024-11-21

Study Completion Date2028-11

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

Chronic Graft-versus-host Disease (cGVHD)