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NCT03740529 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2026-01-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed CLL/SLL, WM, or NHL intolerant to either ≥ 2 prior standard of care regimens given in combination or sequentially OR have received 1 prior BTK inhibitor-containing regimen when a BTK inhibitor is approved as first line therapy (Phase 1) OR with prior treatment defined by phase 2 cohort (Phase 2 Patients only). * Adequate hematologic function (Phase 1 and 1b Patients only). * Responsive to transfusion support if given for thrombocytopenia or anemia (Phase 1 and 1b Patients only). * Histologically confirmed relapsed/recurrent CLL in whom venetoclax is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm A Patients only). * Histologically confirmed relapsed/refractory CLL in whom venetoclax + rituximab is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm B Patients only). * Eastern Cooperative Oncology Group (ECOG) 0-2. * Adequate hepatic and renal function. * Ability to receive study drug therapy orally. * Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control. Exclusion Criteria: * Investigational agent or anticancer therapy within 5 half-lives or 14 days, whichever is shorter, prior to planned start of specified study therapy except antineoplastic and immunosuppressant monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to the first dose of pirtobrutinib. In addition, no concurrent systemic anticancer therapy is permitted. * Major surgery within 4 weeks prior to planned start of specified study therapy. * Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment. * Pregnancy or lactation. * Patients requiring therapeutic anticoagulation with warfarin. * Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 or greater at the time of starting study treatment except for alopecia. * History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days (180 days before the PK trigger) prior to planned start of specified study therapy. * Known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible and enrolled to phase 2 Cohort 7 if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval. * Active uncontrolled auto-immune cytopenia where new therapy introduced or concomitant therapy escalated within the 4 weeks prior to study enrollment is required to maintain adequate blood counts. * Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of pirtobrutinib. * Active uncontrolled systemic bacterial, viral, fungal or parasitic infection. * Patients who have tested positive for human immunodeficiency virus (HIV) are excluded. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment. * Clinically significant active malabsorption syndrome. * Current treatment with certain strong CYP3A4 inhibitors or inducers and/or strong P-gp inhibitors. * For patients enrolled to phase 1b Arm A or B: Patients with prior treatment with venetoclax or other BCL-2 inhibitors. * Prior treatment with pirtobrutinib. * Active second malignancy unless in remission and with life expectancy \> 2 years. * Known hypersensitivity to any component or excipient of pirtobrutinib. * For patients enrolled to phase 1b Arm B: Patients with prior significant hypersensitivity, allergy, or anaphylactic reaction to rituximab/biosimilar requiring discontinuation. * Patients with prior significant hypersensitivity to rituximab requiring discontinuation, prior allergic or anaphylactic reaction to rituximab (Phase 1b Arm B Patients only).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Dose Escalation and determination of MTD; multiple dose levels of pirtobrutinib to be evaluated
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase I Dose Escalation (Pirtobrutinib Monotherapy)
    type
    EXPERIMENTAL
  2. description
    CLL/SLL patients with no prior therapy.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 3
    type
    EXPERIMENTAL
  3. description
    Non-blastoid MCL patients treated with a prior BTK-inhibitor containing regimen.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 1
    type
    EXPERIMENTAL
  4. description
    CLL/SLL patients treated with prior therapy, BTK inhibitor naïve.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 4
    type
    EXPERIMENTAL
  5. description
    CLL/SLL patients treated with 2 or more prior regimens, including a BTK inhibitor-containing regimen.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 2
    type
    EXPERIMENTAL
  6. description
    WM patients treated with a prior BTK inhibitor-containing regimen.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 5
    type
    EXPERIMENTAL
  7. description
    MZL patients treated with a prior BTK inhibitor-containing regimen.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 6
    type
    EXPERIMENTAL
  8. description
    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.
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
    type
    EXPERIMENTAL
  9. description
    Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax
    intervention Names
    1. Drug: Pirtobrutinib
    2. Drug: Venetoclax
    label
    Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
    type
    EXPERIMENTAL
  10. description
    Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax and rituximab
    intervention Names
    1. Drug: Pirtobrutinib
    2. Drug: Venetoclax
    3. Drug: Rituximab
    label
    Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
    type
    EXPERIMENTAL
  11. description
    Patients to receive the recommended Phase 2 dose of pirtobrutinib
    intervention Names
    1. Drug: Pirtobrutinib
    label
    Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)
    2. Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
    3. Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
    4. Phase 2 (Pirtobrutinib Monotherapy) Cohort 1
    5. Phase 2 (Pirtobrutinib Monotherapy) Cohort 2
    6. Phase 2 (Pirtobrutinib Monotherapy) Cohort 3
    7. Phase 2 (Pirtobrutinib Monotherapy) Cohort 4
    8. Phase 2 (Pirtobrutinib Monotherapy) Cohort 5
    9. Phase 2 (Pirtobrutinib Monotherapy) Cohort 6
    10. Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
    11. Phase I Dose Escalation (Pirtobrutinib Monotherapy)
    description
    Oral
    name
    Pirtobrutinib
    other Names
    1. LOXO-305
    2. LY3527727
    type
    DRUG
  2. arm Group Labels
    1. Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
    2. Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
    description
    Oral
    name
    Venetoclax
    other Names
    1. Venclexta, Venclyxto
    type
    DRUG
  3. arm Group Labels
    1. Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
    description
    IV
    name
    Rituximab
    other Names
    1. Rituxan
    2. MabThera
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
803
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Phase I
    measure
    Maximum Tolerated Dose (MTD)
    time Frame
    Up to 24 Months
  2. description
    Phase I
    measure
    Recommended dose for further study
    time Frame
    Up to 24 Months
  3. description
    Phase II
    measure
    To assess the preliminary anti-tumor activity of pirtobrutinib based on ORR as assessed by an Independent Review Committee (IRC).
    time Frame
    Up to 24 months
  4. description
    For Phase 1b
    measure
    To evaluate the safety of pirtobrutinib in combination with venetoclax (Arm A) by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
    time Frame
    Up to 24 Months
  5. description
    For Phase 1b
    measure
    To evaluate the safety of pirtobrutinib in combination with venetoclax and rituximab (Arm B) by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
    time Frame
    Up to 24 Months
secondary Outcomes
  1. description
    Phase I
    measure
    To determine the safety profile and tolerability of pirtobrutinib including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events.
    time Frame
    Up to 24 Months
  2. description
    Phase I
    measure
    To characterize the pharmacokinetics (PK) properties of pirtobrutinib by collecting and evaluating serum at protocol specified time points.
    time Frame
    Up to 24 Months
  3. description
    Phase I
    measure
    To assess the preliminary anti-tumor activity of pirtobrutinib based on overall response rate (ORR) as assessed by investigator.
    time Frame
    Up to 24 Months
  4. description
    Phase II
    measure
    ORR as assessed by the Investigator.
    time Frame
    Up to 24 Months
  5. description
    Phase II
    measure
    Best overall response (BOR) as assessed by the Investigator and IRC.
    time Frame
    Up to 24 Months
  6. description
    Phase II
    measure
    Duration of response (DOR) as assessed by the Investigator and IRC.
    time Frame
    Up to 24 Months
  7. description
    Phase II
    measure
    Progression free survival (PFS) as assessed by the Investigator and IRC.
    time Frame
    Up to 24 Months
  8. description
    Phase II
    measure
    Overall survival (OS).
    time Frame
    Up to 24 Months
  9. description
    Phase II
    measure
    To determine the safety profile and tolerability of pirtobrutinib including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events
    time Frame
    Up to 24 Months
  10. description
    Phase II
    measure
    To characterize the pharmacokinetics (PK) properties of pirtobrutinib by collecting and evaluating serum at protocol specified time points.
    time Frame
    Up to 24 Months
  11. description
    For Phase 1b
    measure
    To characterize the pharmacokinetics (PK) properties of pirtobrutinib by collecting and evaluating serum at protocol specified time points.
    time Frame
    Up to 24 months
  12. description
    For Phase 1b
    measure
    To assess the preliminary anti-tumor activity of pirtobrutinib in combination based on overall response rate (ORR) as assessed by investigator.
    time Frame
    Up to 24 months
Full study description
brief Summary
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.
detailed Description
This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form is 25 mg/day (e.g., 25 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in Phase 1 dose escalation, enrollment will continue to Phase 1 dose expansion and can commence to Phase 1b (Arms A and B). For Phase 2, patients will be enrolled to one of seven Phase 2 dose expansion cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.
Source references
references
  1. citation
    Palomba ML, Patel MR, Eyre TA, Jurczak W, Lewis D, Gastinne T, Ma S, Cohen JB, Patel K, Brown JR, Scarfo L, Munir T, Lech-Maranda E, Hoffmann MS, Ujjani CS, Fakhri B, Wang ML, Izutsu K, Nagai H, Tam CS, Rhodes JM, Vose J, McKinney M, Gerson JN, Barve MA, Kuss B, Koh Y, Barrett A, Treon SP, Castillo JJ, Seymour JF, Ruppert AS, McNeely SC, Walgren RA, Tsai DE, Bao K, Nair B, Woyach J, Cheah CY. Safety and activity of pirtobrutinib in patients with relapsed or refractory Waldenstrom macroglobulinaemia: 5-year follow-up of the open-label, multicentre, phase 1/2 BRUIN trial. Lancet Haematol. 2026 May;13(5):e284-e296. doi: 10.1016/S2352-3026(26)00037-2.
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    40845254
    type
    DERIVED
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    pmid
    39415923
    type
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    39033770
    type
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    Roeker LE, Woyach JA, Cheah CY, Coombs CC, Shah NN, Wierda WG, Patel MR, Lamanna N, Tsai DE, Nair B, Wang C, Zhao X, Liu D, Radtke D, Chapman S, Marella N, McNeely SC, Brown JR. Fixed-duration pirtobrutinib plus venetoclax with or without rituximab in relapsed/refractory CLL: the phase 1b BRUIN trial. Blood. 2024 Sep 26;144(13):1374-1386. doi: 10.1182/blood.2024024510.
    pmid
    38861666
    type
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  8. citation
    Telaraja D, Kasamon YL, Collazo JS, Leong R, Wang K, Li P, Dahmane E, Yang Y, Earp J, Grimstein M, Rodriguez LR, Theoret MR, Gormley NJ. FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma. Clin Cancer Res. 2024 Jan 5;30(1):17-22. doi: 10.1158/1078-0432.CCR-23-1272.
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Source notices and limitations
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        14 CLINICAL STUDIES 14.1 Mantle Cell Lymphoma The efficacy of JAYPIRCA in patients with MCL was evaluated in BRUIN [NCT03740529], an open-label, international, multicohort, single-arm study of JAYPIRCA as monotherapy. Efficacy was based on 120 patients with MCL treated with JAYPIRCA who
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        CI) 8.3 (5.7, NE) 14.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma BRUIN The efficacy of JAYPIRCA in patients with CLL/SLL was evaluated in BRUIN [NCT03740529] an open-label, international, single-arm, multicohort study of JAYPIRCA as monotherapy. Efficacy was based on 108 patients with CLL/SLL treated with JAYPIRCA
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      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      spl effective time
      20260306
      spl set id
      bd551845-0878-49a4-860f-839b83f6b801

    Preserved source evidence · Not medical advice