A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Brief summary

Progression-free Survival (PFS) per Lugano Response Criteria

Detailed description

Complete Response (CR) at End of Treatment (EOT) per Lugano Response Criteria, Overall Survival (OS), Event-free Survival (EFS) per Lugano Response Criteria, Duration of CR, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score, Change From Baseline in HRQoL on FACT-Lym Total Score, Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) score, Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGVINCRISTINE

DRUGDOXORUBICIN

DRUGCYCLOPHOSPHAMIDE

DRUG-

DRUGPREDNISONE

DRUGZilovertamab vedotin

DRUGPREDNISOLONE

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS) per Lugano Response Criteria	—

Secondary

Measure	Time frame
Complete Response (CR) at End of Treatment (EOT) per Lugano Response Criteria, Overall Survival (OS), Event-free Survival (EFS) per Lugano Response Criteria, Duration of CR, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score, Change From Baseline in HRQoL on FACT-Lym Total Score, Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) score, Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score	—

Measure

Time frame

Complete Response (CR) at End of Treatment (EOT) per Lugano Response Criteria, Overall Survival (OS), Event-free Survival (EFS) per Lugano Response Criteria, Duration of CR, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score, Change From Baseline in HRQoL on FACT-Lym Total Score, Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) score, Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score

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Countries

Belgium, Denmark, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed