Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Conditions

• Mantle-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Administered orally once daily
• Venetoclax — DRUG
  Administered orally once daily
• Placebo Oral tablet to match Venetoclax — DRUG
  Administered orally once daily

Study Details

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Key Dates

Start date

Jun 19, 2017

Status verified

Jul 2025

Primary completion

Jun 26, 2024

Completion

Jun 27, 2024

Study Design

Enrollment

366 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Run-in
  Participants with a low or high risk of TLS enroll into the open-label Safety Run-in Period to receive concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramp up to a target dose of 400 mg once daily over a 5-week period.
• Experimental: Randomization Phase: Ibrutinb + Venetoclax
  Participants randomized to ibrutinib and venetoclax for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax is discontinued after 104 weeks of treatment, regardless of response assessment.
• Placebo Comparator: Randomization Phase: Ibrutinib + Placebo
  Participants randomized to ibrutinib and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo is discontinued after 104 weeks of treatment, regardless of response assessment.
• Experimental: Treatment-naive Open-label Arm
  Participants are treated with ibrutinib 560 mg and venetoclax 400 mg, administered using the 5-week ramp-up schedule.

Primary Outcome Measure

Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) [ Time Frame: After at least 3 months of treatment, with an overall median treatment duration of 20.0 months ]

Locations (14)

Find similar trials in Tucson, AZ

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