BridgeMD
Compares treatment options for Chronic Graft-versus-host Disease (cGVHD)
Official title Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
ClinicalTrials.gov ID: NCT06660355
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, being studied as a potential treatment for chronic graft-versus-host disease (cgvhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.
- Able to take oral medications.
You likely can't join if
- Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive...
- Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within...
- 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.
See the full eligibility 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:
- absolute neutrophil count ≥1,000/mcL
- platelets ≥30,000/mcL
- Hemoglobin ≥ 7 g/dL
- Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH d. AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN unless attributable to GVH e. creatinine clearance ≥30 ml/min
- 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...
- 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...
- 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...
- Current or history of active Tuberculosis.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Tampa, Florida, United States
- Kansas City, Kansas, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Tampa, Florida, United States; Kansas City, Kansas, United States; Charlottesville, Virginia, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.