A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

ConditionRelapsed/Refractory Diffuse Large B-Cell Lymphoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorHutchmed

About this trial

This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with R/R DLBCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign the ICF and be able to follow the requirements of study protocol;

Age ≥18 years;

ECOG performance status score between 0 and 2;

Histopathologically confirmed diagnosis of DLBCL;

Disqualifiers

Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;

Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;

Organ insufficiency;

Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);

Trial design

Design model

Parallel

Treatments tested in this trial

HMPL-760
Drug
Patients will receive HMPL-760 once daily (QD) orally.
HMPL-760 Placebo
Drug
Patients will receive HMPL-760 placebo once daily (QD) orally.
R-GemOx
Drug
R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg/m2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV is given on Day 2 of each cycle.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: The experimental groupExperimental treatment 2 interventions

Group B: The control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Progression-free survival (PFS)

Investigator-assessed progression-free survival (PFS) Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014). PFS is defined as the time from randomization to PD or death due to any cause, whichever occurs first.

Time frame

Up to approximately two years

End of treatment (EOT)

Tumor assessment data will continue to be collected. Tumor assessment data collected after end of treatment (EOT) will be used. Tumor assessment data collected during the study and after EOT will be included in the PFS analysis (treatment policy strategy).

Time frame

Up to approximately two years

Systemic antitumor therapy

Use of other systemic antitumor therapy before PD or death (in the absence of PD):Tumor assessment after use of other systemic antitumor therapy will not be included in the analysis. For patients using other anti-tumor therapy before PD or death (in absence of PD), PFS will be censored at the last evaluable tumor assessment before the use of other systematic anti-tumor therapy (hypothetical strategy).

Time frame

Up to approximately two years

Overall survival (OS)

OS is defined as the time from randomization to death due to any cause.

Time frame

Up to approximately two years

Secondary outcomes

Independent review committee (IRC)-assessed PFS

Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).

Time frame

Up to approximately two years

IRC- and investigator-assessed objective response rate (ORR)

Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR)

Time frame

Up to approximately two years

IRC- and investigator-assessed complete response rate (CRR)

Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR)

Time frame

Up to approximately two years

IRC- and investigator-assessed duration of response (DoR)

For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first

Time frame

Up to approximately two years

Other outcomes

Biomarker assessment

Detect tumor driver gene mutations in tissue and blood samples, such as MYD88 and CD79B, etc, and explore the relationship between their mutation status and drug efficacy.

Time frame

Up to approximately two years

To explore the metabolite profile of HMPL-760 in combination with R-GemOx in tumor patients

Human metabolites of HMPL-760 when co-administered with R-GemOx

Time frame

Up to approximately two years

Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

maximum concentration in steady-state (Cmax,ss)

Time frame

Up to approximately two years

Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

time to maximum concentration in steady-state (Tmax,ss)

Time frame

Up to approximately two years

Locations50

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Sponsors and contacts

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Hutchmed

Lead sponsor

Source ClinicalTrials.gov

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