Status:
ACTIVE_NOT_RECRUITING
Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Lead Sponsor:
Loxo Oncology, Inc.
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to co...
Detailed Description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patient...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
- Previously treated with a covalent BTK inhibitor.
- Eastern Cooperative Oncology Group (ECOG) 0-2.
- Absolute neutrophil count ≥ 0.75 × 10\^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10\^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
- Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
- Platelets ≥ 50 × 10\^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10\^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count \< 30 x 10\^9/L are excluded.
- AST and ALT ≤ 3.0 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN.
- Estimated creatinine clearance of ≥ 30 mL/min.
Exclusion
- Known or suspected Richter's transformation at any time preceding enrollment.
- Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
- Ongoing drug-induced liver injury.
- Active uncontrolled auto-immune cytopenia.
- Significant cardiovascular disease.
- History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
- Active hepatitis B or hepatitis C.
- Known active cytomegalovirus (CMV) infection.
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
- Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
- Clinically significant active malabsorption syndrome or inflammatory bowel disease
- Prior exposure to non-covalent (reversible) BTK inhibitor.
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers.
- Vaccination with a live vaccine within 28 days prior to randomization.
- Patients with the following hypersensitivity:
- Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
- Prior significant hypersensitivity to rituximab.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04666038
Start Date
March 9 2021
End Date
May 1 2027
Last Update
April 20 2025
Active Locations (232)
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1
Southern Cancer Center, P.C.
Daphne, Alabama, United States, 36526
2
Mitchell Cancer Institute -University of South Alabama
Mobile, Alabama, United States, 36604
3
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
4
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, United States, 85711