Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Conditions

• Lymphoma, Mantle-Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pirtobrutinib — DRUG
  Oral
• Ibrutinib — DRUG
  Oral
• Acalabrutinib — DRUG
  Oral
• Zanubrutinib — DRUG
  Oral

Study Details

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Key Dates

Start date

Apr 8, 2021

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Apr 30, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Pirtobrutinib)
  Orally
• Active Comparator: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)
  Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.

Primary Outcome Measure

To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL) [ Time Frame: Up to approximately 24 months ]

Locations (36)

Find similar trials in Anchorage, AK