Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma

This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or partial response (PR) after first-line systemic chemotherapy and are not candidates for hematopoietic stem cell transplantation (HSCT) or decline HSCT. Eligible patients with histologically confirmed PTCL subtypes (PTCL-NOS, ALK-positive anaplastic large cell lymphoma \[ALK-ALCL\], angioimmunoblastic T-cell lymphoma \[AITL\], or follicular helper T-cell phenotype PTCL \

Trial Details

NCT ID
NCT07300514
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • PET-CTandct- DNAdetection
  • golidocitinib
  • Placebo
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements.
  • Age ≥18 years at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening.
  • Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding …

For full eligibility, visit ClinicalTrials.gov.

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