Is NCT05531786 recruiting in Miami, FL?

Yes, NCT05531786 is currently recruiting participants at its Miami, FL location. This graft-versus-host disease clinical trial is actively enrolling qualified participants.

How do I join the graft-versus-host disease clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Graft-Versus-Host Disease Clinical Trial in Miami, FL

About This Graft-Versus-Host Disease Study in Miami

Background: Chronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death. New treatments are needed to treat cGVHD after stem cell transplant. Objective: To test a drug (pacritinib) in people with moderate or severe cGVHD that has not responded to previous treatment. Eligibility: People aged 18 years and older with moderate or severe cGVHD that h

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria

cGVHD that did not respond to \>=2 lines of prior systemic therapy. Disease that has failed prior systemic therapy will be defined as follows: a) For prior corticosteroid-containing regimens, disease that: i) recurs after achievement of a CR, or ii) progresses after achievement of a PR, or iii) progresses after at least 1 week of prednisone equivalent of 1 mg/kg/day, or iv) is stable and persistent after at least 4 weeks of a prednisone equivalent of 0.5 mg/kg/day OR, b) For other systemic therapies, disease that: i) recurs after achievement of CR, or ii) progresses after achievement of a PR, or iii) is stable and persistent despite 4 weeks of therapeutic dosing of systemic therapy

Karnofsky performance score \>=60%

Age \>=18 years.

If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering dose in the preceding 4 weeks.

Participants must have adequate organ and marrow function as defined below:

absolute neutrophil count \>=1,000/mcL

platelets \>=50,000/mcL

total bilirubin \<=1.5 X institutional upper limit of normal OR \<=3 X institutional upper limit of normal in participants with Gilbert's syndrome

AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal

eGFR \>= 35 mL/min per CKD-EPI 2021

Primary malignancy for which the participant received transplant has been in complete clinical remission and stable for 3 months prior to enrollment on study.

Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant who are sexually active must agree to use one (1) highly effective (e.g., intrauterine system containing levonorgestrel intrauterine devices, surgical) or two (2) effective forms of contraception (e.g., barrier method) at study entry, for the duration of study treatment, and for at least 30 days after last study drug exposure.

Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Acute GVHD that is active as defined by exhibiting current signs or symptoms of disease without any chronic GVHD (classic and late-acute GVHD per NIH consensus criteria); participants with a clinical presentation consistent with overlapping acute GVHD with concurrent chronic GVHD will be eligible

Treatment with ruxolitinib within 24 hours, or ibrutinib within the \<=14 days prior to treatment initiation.

Active HIV-1 (detectable HIV viral load), or Hepatitis B (HBV) and/or Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody).

Participants with the following cardiac conditions at screening:

symptomatic congestive heart failure

unstable angina pectoris

uncontrolled cardiac dysrhythmias

QTc(F) prolongation \>450 ms or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome).

Left ventricular ejection fraction \<= 50% by transthoracic echocardiogram (TTE) at screening.

Participants with poor pulmonary function as defined by a forced expiratory volume in the first second (FEV1) \<= 39% calculated using the USA-ITS-NIH equation.

Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.

Concurrent treatment with any other investigational agents.

Concurrent use of strong CYP3A4 inducers or inhibitors, must stop 2 weeks prior study drug initiation.

Known hypersensitivity to JAK inhibitors.

Participants who are unwilling to accept blood transfusions.

Pregnancy or breastfeeding.

Participants with any active, uncontrolled viral, bacterial, or fungal infection are excluded.

Other malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix or breast which requires active treatment.

Uncontrolled intercurrent illness evaluated by history, physical exam and chemistries or situation that would limit compliance with study requirements.

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 (NCT05531786) 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.

Graft-Versus-Host Disease Treatment Options in Miami, FL

If you're searching for graft-versus-host disease treatment options in Miami, FL, this clinical trial (NCT05531786) 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 phase 1/2 clinical trial. You'll receive care from experienced graft-versus-host disease 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 graft-versus-host disease clinical trials near you to find additional studies recruiting in your area.

Graft-Versus-Host Disease Clinical Trial in Miami, FL

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