A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell
• Small Lymphocytic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Ibrutinib capsules will be administered orally.
• Venetoclax — DRUG
  Venetoclax tablets will be administered orally.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).

Key Dates

Start date

May 30, 2024

Status verified

Jun 2026

Primary completion

Dec 15, 2027

Completion

Mar 19, 2029

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.
• Experimental: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.
• Experimental: Cohort 2a: Continuous Ibrutinib Monotherapy
  Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
• Experimental: Cohort 2b: Continuous Ibrutinib Monotherapy
  Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity.

Primary Outcome Measure

Best Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (32)

Find similar trials in Cerritos, CA

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