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Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

ConditionPeripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Accompanied by hemophagocytic lymphohistiocytosis (HLH)

Lymphoma involvement in the central nervous system or meninges

Active infections

Uncontrolled clinical cardiac symptoms or diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Golidocitinib

    Drug

    150mg, po, qd;

  • Mitoxantrone Hydrochloride Liposome

    Drug

    Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)

  • Chidamide

    Drug

    Cohort 2: Chidamide：20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)

Treatment groups

101 Participants
are divided into 1 treatment group
Group A: Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall response rate(ORR) for Phase 2

The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

Time frame
Up to 24 months
2

Maximum tolerated dose (MTD) for Phase 1b

To identify the MTD

Time frame
The first cycle after administration

Secondary outcomes

1

Complete response rate (CRR)

Defined as the proportion of patients who achieve complete remission as the best response

Time frame
Up to 24 months
2

Duration of Response(DOR)

To investigate the preliminary anti-tumor efficacy

Time frame
Up to 4 years
3

Progression-free survival(PFS)

To investigate the preliminary anti-tumor efficacy

Time frame
Up to 4 years
4

Overall survival(OS)

To investigate the preliminary anti-tumor efficacy

Time frame
Up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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