San Francisco, CANCT06663722Now EnrollingIRB Ready

Chronic Graft Versus Host Disease Clinical Trial in San Francisco, CA

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

Sponsored by University of Miami

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Expert Care in San Francisco

Access chronic graft versus host disease 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 treatment provided free

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Check if you qualify for this chronic graft versus host disease clinical trial in San Francisco, CA

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Why Participate?

  • No-Cost Study Care

  • Local to San Francisco

    Convenient for CA 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 San Francisco site if eligible
  4. 4Begin participation

About This Chronic Graft Versus Host Disease Study in San Francisco

The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).

Sponsor: University of Miami

Who Can Participate

Inclusion Criteria

Recipient of allogeneic hematopoietic cell transplantation (HCT).
Age greater or equal to 12.
Chronic GVHD per 2014 National Institutes of Health Consensus Criteria (NCC) (Jagasia et al. 2015) or overlap syndrome requiring new therapy in patients with at least 2 prior lines of therapy, steroid refractoriness, or steroid dependence:
Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such as ruxolitinib, belumosudil, or ibrutinib. GVHD prophylaxis does not count as a prior line of therapy.
Steroid refractory is defined as any of the following criteria:
i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week
ii. Manifestations persist without improvement despite treatment with ≥ 0.5 mg/kg/day or 1 mg/kg every other day for at least four weeks.
iii. Recurrence after a CR, or
iv. Progression after a PR.
Steroid dependence is defined as inability to control cGVHD symptoms while tapering prednisone below 0.25 mg/kg/day on at least two occasions separated by at least 8 weeks. There must be evidence of clinically active cGVHD.
For patients receiving approved or commonly used agents, all GVHD systemic treatments should be discontinued except for corticosteroids and drugs being continued from GVHD prophylaxis at screening.
Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening.
Platelet count \> 50,000 platelets/μL and absolute neutrophil count \> 1,000 cells/μL as measured at Screening.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), unless attributed to presumed cGVHD as measured at Screening.
Stable dose of corticosteroids for at least 14 days prior to treatment.
Sexually mature individuals must use contraception as described in Section 4.12. For individuals less than 18 years of age, sexual maturity will be determined as per treating pediatrician.

Exclusion Criteria

Pregnancy or breast-feeding.
Active relapse of underlying malignancy.
History or the presence of interstitial pneumonitis or drug-related pneumonitis.
Active gastrointestinal (GI) bleeding.
Inability to tolerate volume shifts associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function (ejection fraction (EF) \< 40%) per Investigator discretion.
History of myositis.
History of splenectomy.
History of pancreatitis.
History of other malignancy (within 3 years of Screening) unless treated with curative intent and approved by Principal Investigator (PI).
Significant, uncontrolled, or active comorbid conditions or are unable to adhere to the study requirements.
Acquired Immune Deficiency Syndrome (AIDS) or active hepatitis B (Hep B) or active hepatitis C (Hep C) infection.
Prior colony-stimulating factor-1 (CSF-1R) targeted therapies.
Prior history of ECP treatment failure or intolerance.
Intolerance to methoxsalen, heparin, or citrate products.
Patients with aphakia due to risk of increased retinal damage or photosensitive disease (albinism, systemic lupus erythematosus, porphyria).
Lack of stable IV access. Acceptable forms include central venous catheter, peripherally inserted central catheter (PICC), or peripheral IV line per institutional guidelines.
Insurance denial of coverage for the ECP procedure.

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 San Francisco?

Yes, this clinical trial (NCT06663722) has an active research site in San Francisco, CA 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 Treatment Options in San Francisco, CA

If you're searching for chronic graft versus host disease treatment options in San Francisco, CA, this clinical trial (NCT06663722) 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 San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic 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 chronic graft versus host disease clinical trials near you to find additional studies recruiting in your area.

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