A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pirtobrutinib — DRUG
  Administered orally.
• Ibrutinib — DRUG
  Administered orally.

Study Details

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Key Dates

Start date

Jul 22, 2022

Status verified

Jun 2026

Primary completion

Oct 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

737 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pirtobrutinib Part 1
  Participants will receive pirtobrutinib orally.
• Active Comparator: Ibrutinib Part 1
  Participants will receive ibrutinib orally.
• Experimental: Pirtobrutinib Part 2
  Participants will receive pirtobrutinib orally.

Primary Outcome Measure

Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 [ Time Frame: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months) ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (19)

Find similar trials in Anaheim, CA

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