BridgeMD
Tests treatment safety and results for Chronic Graft Versus Host Disease
Official title Gecacitinib for cGVHD: Safety and Efficacy in Patients After ≥2 Lines of Prior Therapy
ClinicalTrials.gov ID: NCT07012304
What this study is testing
What is Gecacitinib Hydrochloride Tablets?
Gecacitinib Hydrochloride Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic graft versus host disease.
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
- Chronic Graft-versus-Host Disease (cGVHD) is a common late complication following allogeneic hematopoietic stem cell transplantation and a leading non-relapse cause of death. It is often treatment-refractory, significantly affecting patients' quality of life and prognosis.
- Phase 2: a mid-size study of how well it works
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
- Voluntarily Signed informed consent and aged ≥18 years
- Undergone nonmyeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow, peripheral blood stem cells, or umbilical cord blood...
- Confirmed myeloid and platelet engraftment: ANC \>1.0×10⁹/L and platelet count \>25×10⁹/L; no hematopoietic growth factors or blood product...
- Clinically diagnosed moderate-to-severe cGVHD according to the 2014 NIH
- Received 2-5 prior systemic cGVHD therapies with persistent disease
You likely can't join if
- Recurrence of malignancy or loss of full donor chimerism
- Concurrent use of other JAK inhibitors, mesenchymal stem cells, or belumosudil (Eligible if discontinued for \>8 weeks post-aGVHD treatment or...
- Severe pulmonary cGVHD (FEV1 ≤39% or NIH lung symptom score of 3)
- Post-transplant lymphoproliferative disease
- Significant abnormalities affecting safety assessment, such as uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite ≤2...
- History of major cardiovascular events within 6 months.
See the full eligibility criteria
- Voluntarily Signed informed consent and aged ≥18 years
- Undergone nonmyeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow, peripheral blood stem cells, or umbilical cord blood from any donor source
- Confirmed myeloid and platelet engraftment: ANC \>1.0×10⁹/L and platelet count \>25×10⁹/L; no hematopoietic growth factors or blood product transfusions within 7 days before screening
- Clinically diagnosed moderate-to-severe cGVHD according to the 2014 NIH
- Received 2-5 prior systemic cGVHD therapies with persistent disease
- ECOG PS score of 0-2
- Able to swallow tablets
- Concomitant use of non-interacting immunosuppressants permitted
- Recurrence of malignancy or loss of full donor chimerism
- Concurrent use of other JAK inhibitors, mesenchymal stem cells, or belumosudil (Eligible if discontinued for \>8 weeks post-aGVHD treatment or stopped JAK inhibitors for cGVHD due to side effects.)
- Severe pulmonary cGVHD (FEV1 ≤39% or NIH lung symptom score of 3)
- Post-transplant lymphoproliferative disease
- Significant abnormalities affecting safety assessment, such as uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite ≤2 antihypertensives; ALT/AST \>3×ULN; DBIL/TBIL \>1.5×ULN; serum creatinine \>1.5×ULN
- History of major cardiovascular events within 6 months.
- Arrhythmia requiring treatment at screening
- Gastrointestinal conditions impairing drug absorption
- Surgery within 4 weeks of screening with incomplete recovery
- Active/uncontrolled infections (viral, bacterial, parasitic, fungal) requiring treatment
- Active tuberculosis within 6 months
- Epilepsy or use of psychotropic/sedative drugs
- Pregnant/breastfeeding or unwilling to use contraception during and 4 weeks post-study
- Malignancy within 5 years (except the indication for transplant)
- Use of anticoagulants/platelet inhibitors (except low-molecular-weight heparin)
- Herbal medicine use within 1 week prior to enrollment
- Hypersensitivity to gecacitinib or its components
- Participation in another clinical trial within 4 weeks (or 5 half-lives of the previous study drug, whichever is longer)
- Deemed unsuitable by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
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 Beijing, China. 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.