Trial Profile
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 09 Mar 2026
Price :
$35
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At a glance
- Drugs Pirtobrutinib (Primary) ; Bendamustine; Idelalisib; Rituximab
- Indications Chronic lymphocytic leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms BRUIN CLL-321
- Sponsors Loxo Oncology
Most Recent Events
- 01 Mar 2026 According to Innovent Biologics media release, Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL-321 study in China.
- 01 Mar 2026 According to Innovent Biologics media release, company announced that Jaypirca (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Brutons tyrosine kinase (BTK) inhibitor.
- 03 Dec 2025 According to an Eli Lilly and Company media release, based on data from this trial, the U.S. Food and Drug Administration has approved Jaypirca (pirtobrutinib; 100 mg and 50 mg tablets) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a covalent Bruton tyrosine kinase inhibitor, expanding the label to patients earlier in their treatment course and converting the December 2023 accelerated approval to a traditional approval.