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.
This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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)
Assessed per Lugano criteria
Time frame: Up to approximately 24 months
To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death
Time frame: Up to approximately 24 months
To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time from randomization to time when discontinuation criteria met
Time frame: Up to approximately 24 months
Time to worsening (TTW) of MCL-related symptoms
Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Time frame: Up to approximately 24 months
Comparative Tolerability as measured by proportion of time with high side effect burden
Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.
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Oral
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States
Arizona Oncology Associates, P.C. - HOPE
Phoenix, Arizona, United States
UCLA Medical Center
Los Angeles, California, United States
USO-Rocky Mountain Cancer Center
Denver, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Oncology-Hematology Associates of West Broward
Tamarac, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Mercy Health-Paducah Medical Oncology and Hematology
Paducah, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States
...and 179 more locations
Time frame: Up to approximately 24 months
To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed per Lugano criteria
Time frame: Up to approximately 24 months
To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed per Lugano criteria
Time frame: Up to approximately 24 months
To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed by survival
Time frame: Up to approximately 24 months