Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorGreat Novel Therapeutics Biotech & Medicals Corporation
About this trial
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.
Eligibility criteria
Qualifiers
Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.
Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
Male or female, aged 20-75 years (inclusive).
Disqualifiers
Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
Have been treated with histone deacetylase (HDAC) inhibitor.
With a history of clinically significant QTc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.
Trial design
Treatments tested in this trial
- Chidamide
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov