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Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL

ConditionsPTCLRefractory
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

To evaluate the safety and efficacy of Zeprumetostat-based combination therapy, selected according to genotyping results, in patients with primary refractory peripheral T-cell lymphoma (PTCL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

Patients with a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) based on 2016 WHO classification

Previously treated with 3 or 6 cycles of a CHOP-like regimen as first-line therapy and considered primary refractory. Patients with anaplastic large cell lymphoma (ALCL) must have adequately received brentuximab vedotin (BV) as part of their first-line treatment.

Tumor tissue genotyping performed and results available prior to enrollment.

Disqualifiers

Has a prior malignancy other than the malignancies under study within 3 years without relieve

Primary CNS lymphoma

Known hypersensitivity to any study drug.

Pregnant or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zeprumetostat+Azacitadine

    Drug

    Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Azacitadine :100mg D1-D7, subcutaneous injection, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Azacitidine 100 mg D1-D5, subcutaneous injection for total 3 cycles.

  • Zeprumetostat+Decitabine

    Drug

    Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Decitabine 10mg/m2 D1-D5, intravenous infusion, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Decitabine 10mg/m2 D1-D3 for total 3 cycles.

  • Zeprumetostat+Chidamide

    Drug

    Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Chidamide 30 mg biw orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Chidamide 20 mg biw for total 3 cycles.

  • Zeprumetostat+Golidocitinib

    Drug

    Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Golidocitinib 150 mg qd orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Golidocitinib 150 mg qod for total 3 cycles.

Treatment groups

86 Participants
are divided into 4 treatment groups
Group A: Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation)Experimental treatment 1 intervention
Group B: Zeprumetostat+Decitabine (if with TP53 gene mutation)Experimental treatment 1 intervention
Group C: Zeprumetostat+Chidamide (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation)Experimental treatment 1 intervention
Group D: Zeprumetostat+Golidocitinib (if not above genotype)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Summary of DLT events (Phase Ib)

Measure Description: Enroll 6 pts per cohort and observe the number of pts experiencing dose-limiting toxicity.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

Overall response rate (Phase Ⅱ)

Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Time frame
At the end of Cycle 3 (each cycle is 28 days)

Secondary outcomes

1

Complete response rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Time frame
At the end of Cycle 3
2

Disease Control Rate

Percentage of participants with complete response, partial response, or stable disease, as determined by investigator assessment according to the 2014 Lugano criteria, at the end of Cycle 3

Time frame
each cycle is 28 days
3

Duration of response

Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Time frame
Baseline up to data cut-off
4

Duration of complete response

Time from first occurrence of documented CR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Time frame
Baseline up to data cut-off

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

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