A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.
Eligibility criteria
Qualifiers
Patients must demonstrate a comprehensive understanding of the study protocol, voluntarily consent to participation, and execute the informed consent document.
Inclusive of both genders, participants must be aged 18 years or older and not exceed 80 years of age.
Histopathological confirmation of peripheral T-cell lymphoma (PTCL) must adhere to the World Health Organization (WHO) 2016 classification criteria. This encompasses a range of PTCL subtypes, including but not limited to peripheral T cell lymphoma not otherwise specified (PTCL NOS), vascular immunoblastic T cell lymphoma (AITL), NK/T cell lymphoma, anaplastic large cell lymphoma ALK positive (ALCL ALK+), anaplastic large cell lymphoma ALK negative (ALCL ALK-), enteropathy-associated T-cell lymphoma, hepato-splenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and other subtypes deemed eligible for study participation by the investigators.
Subjects must exhibit relapsed or refractory disease following prior systemic therapy, which may include autologous hematopoietic stem cell transplantation. Relapse is characterized by disease recurrence post-complete response (CR), whereas refractory disease is indicated by stable disease (SD) or progressive disease (PD) following systemic chemotherapy, or by the absence of CR upon treatment completion necessitating further intervention.
Disqualifiers
Presence of hemophagocytic syndrome.
Involvement of the central nervous system or meninges by lymphoma.
A history of malignant tumors within the past five years, with the exception of locally curable tumors that have been subjected to radical treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
History of any of the following treatments:(1) Allogeneic hematopoietic stem cell transplantation prior to the administration of the investigational drug; (2) Autologous hematopoietic stem cell transplantation within six months preceding study drug administration; (3) Previous use of golidocitinib or pomalidomide; (4) Current use of vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to discontinue within one week prior to study commencement); (5) Requirement for systemic glucocorticoid therapy or other immunosuppressive therapy for any condition within 14 days prior to study initiation; topical, ocular, intraarticular, intranasal, and inhaled glucocorticoids are permitted; short-term (≤7 days) glucocorticoid use for prophylactic treatment or non-autoimmune diseases is allowed; (6) Cytotoxic chemotherapy must not have been terminated within 21 days before the start of the study; (7) Received systemic antineoplastic therapy (including macromolecular monoclonal antibodies and immunotherapy drugs) within four weeks of study initiation; (8) Undergone major surgery (excluding vascular access surgery) or experienced serious trauma within four weeks before the start of the study; or received radiation therapy within three weeks; (9) Received other toxin/isotope-immune antibody conjugates within ten weeks; (10) For other types of new drug use, the researcher shall make a determination after comprehensive assessment; (11) Received an experimental drug or investigational drug in another trial within 30 days prior to study commencement; (12) Received live vaccines (except attenuated influenza vaccines) 28 days prior to study drug administration.
Trial design
Treatments tested in this trial
- Golicitinib combined with Pomadomide
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov