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

Condition(s) studied

Investigational drug(s) / intervention(s)

HMPL-760: Patients will receive HMPL-760 once daily (QD) orally.

HMPL-760 Placebo: Patients will receive HMPL-760 placebo once daily (QD) orally.

R-GemOx: 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.

Study summary

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

Primary outcome measure(s)

• Progression-free survival (PFS) — Up to approximately two years
  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.
• End of treatment (EOT) — Up to approximately two years
  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).
• Systemic antitumor therapy — Up to approximately two years
  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).
• Overall survival (OS) — Up to approximately two years
  OS is defined as the time from randomization to death due to any cause.
• systematic anti-tumor therapy — Up to approximately two years
  OS data will continue to be collected after the other systematic anti-tumor therapy, and the OS data collected before and after other systematic anti-tumor therapy will be included in analysis (treatment policy strategy).
• Premature withdrawal from study treatment — Up to approximately two years
  OS data will continue to be collected after the patient's premature withdrawal from study treatment, and the OS data collected during the study treatment and after EOT will be included in analysis (treatment policy strategy).

Trial sites (50)

+ 10 more sites — see the full list on the official registry below.

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