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A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.

About this trial

This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with relapsed or refractory non-GCB DLBCL.

Have at least one measurable lesion according to the Lugano Response Criteria 2014.

ECOG performance status 0-2 (0-1 for dose escalation part).

Life expectancy ≥ 12 weeks.

Disqualifiers

Intolerance to Rocbrutinib or any drug in the combination regimen.

Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx.

DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL.

Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rocbrutinib

    Drug

    Patients will receive Rocbrutinib until disease progression or unacceptable toxicity

  • R-GemOx

    Drug

    Patients will receive 6 cycles every 21 days of R-GemOx. Rituximab 375mg/m2 i.v. on day 1 of every cycle. GemOx (gemcitabine 1000mg/m2 plus oxaliplatin 100mg/m2) i.v. on day 2 of each cycle.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Dose Level 1Experimental treatment 2 interventions
Group B: Dose Level 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DLTs

Dose-Limiting Toxicities

Time frame
At the end of Cycle 1 (the length of cycle 1 is 21 days)
2

MTD

Maximum Tolerated Dose

Time frame
At the end of Cycle 1 (the length of cycle 1 is 21 days)
3

Adverse events as assessed by CTCAE v5.0

Time frame
From the first administration to 28 days after the last administration

Secondary outcomes

1

ORR

Overall Response Rate

Time frame
Up to approximately two years
2

TTR

Time to Response

Time frame
Up to approximately two years
3

DoR

Duration of Response

Time frame
Up to approximately two years
4

PFS

Progression-free Survival

Time frame
Up to approximately two years

Other outcomes

Sponsors and contacts

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

Guangzhou Lupeng Pharmaceutical Company LTD.

Lead sponsor

Source ClinicalTrials.gov
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