Peripheral T Cell Lymphoma
Conditions
Brief summary
This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Interventions
DRUGGolidocitinib
150mg, po, qd;
DRUGMitoxantrone Hydrochloride Liposome
Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)
DRUGChidamide
Cohort 2: Chidamide：20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures; * Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center * Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion * Age ≥ 18 years * Expected survival greater than 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Adequate organ and bone marrow function
Exclusion criteria
* Accompanied by hemophagocytic lymphohistiocytosis (HLH) * Lymphoma involvement in the central nervous system or meninges * Active infections * Uncontrolled clinical cardiac symptoms or diseases * Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor. * Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment). * History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS). * Patients with mental disorders or those unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) for Phase 2 | Up to 24 months | The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response. |
| Maximum tolerated dose (MTD) for Phase 1b | The first cycle after administration | To identify the MTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CRR) | Up to 24 months | Defined as the proportion of patients who achieve complete remission as the best response |
| Duration of Response(DOR) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
| Progression-free survival(PFS) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
| Overall survival(OS) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
Countries
China
Contacts
Primary ContactQingqing Cai
Outcome results
None listed