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Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)

ConditionT-cell Lymphomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent;

Adult ≥ 18 years of age;

ECOG performance status score ≤ 2;

Life expectancy of not less than 12 weeks;

Disqualifiers

Presence of unresolved drug-related adverse events greater than Grade 1;

Lymphoma involving the central nervous system;

Failure to complete the required washout period for other anti-tumor therapies;

Corticosteroid use that does not meet protocol requirements;

Trial design

Design model

Single group

Treatments tested in this trial

  • GW5282 combined with Golidocitinib

    Drug

    GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated.

  • GW5282 combined with Golidocitinib

    Drug

    GW5282 and Golidocitinib will be administered at the doses determined during escalation part.

  • Conventional CHOP regimen

    Drug

    CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Dose escalation cohorts (Part A, non-randomized)Experimental treatment 1 intervention
Group B: Dose expansion cohorts (Part B, randomized)Experimental treatment 1 intervention
Group C: Control cohort (Part B, randomized)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame.

Time frame
The DLT observation period is defined as the 21 days after the first dose.
2

Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review

To evaluate anti-tumor activity of GW5282 combined with golidocitinib as a chemo-free induction therapy for newly diagnosed PTCL, and compare it with conventional CHOP regimen.

Time frame
Up to 6 cycles, each cycle is 21 days

Secondary outcomes

1

Part A: Plasma concentration of GW5282 and golidocitinib

To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together

Time frame
C1D1, C1D15, and Day 1 of Cycle 2~9
2

Part A: Efficacy parameters

To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR)

Time frame
through the study completion, an average of around 1~2 years
3

Part A: Efficacy parameters

To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Complete Response Rate (CRR)

Time frame
through the study completion, an average of around 1~2 years
4

Part A: Efficacy parameters

To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Duration of Response (DoR)

Time frame
through the study completion, an average of around 1~2 years

Other outcomes

Sponsors and contacts

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

Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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