A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

Conditions

• B-cell Lymphoma
• Chronic Lymphocytic Leukemia
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma
• Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pirtobrutinib — DRUG
  Oral
• Venetoclax — DRUG
  Oral
• Rituximab — DRUG
  IV

Study Details

This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Key Dates

Start date

Mar 15, 2019

Status verified

Jan 2026

Primary completion

Jan 27, 2025

Completion

Dec 23, 2025

Study Design

Enrollment

803 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I Dose Escalation (Pirtobrutinib Monotherapy)
  Dose Escalation and determination of MTD; multiple dose levels of pirtobrutinib to be evaluated
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 3
  CLL/SLL patients with no prior therapy.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 1
  Non-blastoid MCL patients treated with a prior BTK-inhibitor containing regimen.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 4
  CLL/SLL patients treated with prior therapy, BTK inhibitor naïve.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 2
  CLL/SLL patients treated with 2 or more prior regimens, including a BTK inhibitor-containing regimen.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 5
  WM patients treated with a prior BTK inhibitor-containing regimen.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 6
  MZL patients treated with a prior BTK inhibitor-containing regimen.
• Experimental: Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
  Defined as CLL/SLL or NHL not otherwise specified in Cohorts 1 through 6, inclusive of CLL/SLL, Richter's transformation, or low grade NHL with transformation, blastoid MCL, and patients with history of CNS involvement or primary CNS lymphoma. In the event the Sponsor electively closes Cohorts 2-4 prior to completion, patients with CLL/SLL who are ineligible to participate in or unable to access late phase studies of pirtobrutinib may be eligible to enroll in this cohort Diffuse large B-cell lymphoma (DLBCL) is excluded. MCL without prior BTK inhibitor treatment is excluded. Patients enrolling to Cohort 7 must have received one or more prior therapies or have no available approved therapy with demonstrated clinical benefit with the exception of untreated Richter's transformation, which is allowed.
• Experimental: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
  Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax
• Experimental: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
  Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax and rituximab
• Experimental: Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)
  Patients to receive the recommended Phase 2 dose of pirtobrutinib

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 Months ]

Locations (31)

Find similar trials in Scottsdale, AZ

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