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

ConditionsChronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cellSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoxo Oncology, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria

Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Adequate organ function

Disqualifiers

Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment

Known or suspected central nervous system (CNS) involvement

A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease

Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pirtobrutinib

    Drug

    Administered orally.

  • Ibrutinib

    Drug

    Administered orally.

Treatment groups

737 Participants
are divided into 3 treatment groups
Group A: Pirtobrutinib Part 1Experimental treatment 1 intervention
Group B: Ibrutinib Part 1Active comparator 1 intervention
Group C: Pirtobrutinib Part 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

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)
2

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 2

ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

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 2 years and 3 months)

Secondary outcomes

1

IRC-assessed Progression-Free Survival (PFS)

PFS by IRC per iwCLL 2018 criteria

Time frame
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
2

Investigator assessed Progression-Free Survival (PFS)

PFS by Investigator per iwCLL 2018 criteria

Time frame
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
3

Event-Free Survival (EFS)

EFS by IRC per iwCLL 2018 criteria

Time frame
Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)
4

Duration of Response (DOR)

DOR by IRC and Investigator by iwCLL 2018 Criteria.

Time frame
Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loxo Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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