Trial NCT06588478
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Phase
- Phase 2
- Sponsor
- Loxo Oncology, Inc.
- Conditions
- Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
* Part 1: Have received prior CLL/SLL treatment
* Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
* Have received a covalent BTK inhibitor
* Part 2: Have received no prior treatment for CLL/SLL
* Part 1 - Known 17p deletion status (positive or negative)
* Part 2 - Must have 17p deletion (positive)
* Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
* Capable of swallowing oral study medication.
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.Performance status
Exclusion Criteria:
* Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
* Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
* Have known or suspected Richter's transformation
* Have known or suspected history of central nervous system involvement by CLL/SLLBrain metastases
* Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization.Prior malignancy Exceptions may occur with documented sponsor approval. Examples include:
* nonmelanoma skin cancer or lentigo malignant melanoma
* cervical carcinoma in situ
* localized prostate cancer undergoing active surveillance, and
* localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 to 2
Show in the text - Prior malignancyOutrightexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Boston Medical Center · Boston, Suffolk County