A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.

Conditions

Follicular Lymphoma

Brief summary

Part 1: Number of Participants Who Experience an Adverse Event (AE), Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT), Part 1: Complete Response (CR) Rate, Part 2: Progression-Free Survival (PFS)

Detailed description

Part 1: Objective Response Rate (ORR), Part 1: Duration of CR, Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045, Part 1: Maximum Concentration (Cmax) of MK-1045, Part 1: Trough Concentration (Ctrough) of MK-1045, Part 2: CR Rate at 30 Months, Part 2: ORR, Part 2: Overall Survival (OS), Part 2: Event-Free Survival (EFS), Part 2: Duration of CR, Part 2: Number of Participants Who Experience an AE, Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI), Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score, Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)

Related papers

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Interventions

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGTruxima 100 mg concentrate for solution for infusion

DRUGTOCILIZUMAB

DRUGRITUXIMAB

DRUGCYCLOPHOSPHAMIDE

DRUGDOXORUBICIN

DRUGRuxience 100 mg concentrate for solution for infusion

DRUGPREDNISONE

DRUGRuxience 500 mg concentrate for solution for infusion

DRUGMK-1045

DRUGBENDAMUSTINE

DRUGPREDNISOLONE

DRUGVINCRISTINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Number of Participants Who Experience an Adverse Event (AE), Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT), Part 1: Complete Response (CR) Rate, Part 2: Progression-Free Survival (PFS)	—

Secondary

Measure	Time frame
Part 1: Objective Response Rate (ORR), Part 1: Duration of CR, Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045, Part 1: Maximum Concentration (Cmax) of MK-1045, Part 1: Trough Concentration (Ctrough) of MK-1045, Part 2: CR Rate at 30 Months, Part 2: ORR, Part 2: Overall Survival (OS), Part 2: Event-Free Survival (EFS), Part 2: Duration of CR, Part 2: Number of Participants Who Experience an AE, Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI), Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score, Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)	—

Measure

Time frame

Part 1: Objective Response Rate (ORR), Part 1: Duration of CR, Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045, Part 1: Maximum Concentration (Cmax) of MK-1045, Part 1: Trough Concentration (Ctrough) of MK-1045, Part 2: CR Rate at 30 Months, Part 2: ORR, Part 2: Overall Survival (OS), Part 2: Event-Free Survival (EFS), Part 2: Duration of CR, Part 2: Number of Participants Who Experience an AE, Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI), Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score, Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)

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Outcome results

None listed