Miami, FLNCT06660355Now EnrollingIRB Ready

Chronic Graft-versus-host Disease (cGVHD) Clinical Trial in Miami, FL

Access cutting-edge chronic graft-versus-host disease (cgvhd) treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute

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Expert Care in Miami

Access chronic graft-versus-host disease (cgvhd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic graft-versus-host disease (cgvhd) treatment provided free

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Check if you qualify for this chronic graft-versus-host disease (cgvhd) clinical trial in Miami, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Chronic Graft-versus-host Disease (cGVHD) Study in Miami

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.

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

Inclusion 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 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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT06660355) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Graft-versus-host Disease (cGVHD) Treatment Options in Miami, FL

If you're searching for chronic graft-versus-host disease (cgvhd) treatment options in Miami, FL, this clinical trial (NCT06660355) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic graft-versus-host disease (cgvhd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic graft-versus-host disease (cgvhd) clinical trials near you to find additional studies recruiting in your area.

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