J2N-MC-JZNX


J2N-MC-JZNX: A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/​Small Lymphocytic Lymphoma

Trial summary:

The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The study is expected to last approximately 3 years.

Receptor status / problem studied:

Inclusion criteria

1) Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.

2) Have received prior CLL/SLL treatment

3) Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL.

4) Have received a covalent BTK inhibitor.

5) Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy.

6) Capable of swallowing oral study medication.

7) Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Exclusion criteria

1) Have received prior treatment with a BTK degrader and a noncovalent BTK inhibitor.

2) Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor.

3) Have known or suspected Richter’s transformation.

4) Have known or suspected history of central nervous system involvement by CLL/SLL.

5) Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
|— a) Non-melanoma skin cancer or lentigo maligna melanoma;
|— b) Cervical carcinoma in situ;
|— c) Localized prostate cancer undergoing active surveillance, and;
|— d) 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.

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Trial Title

J2N-MC-JZNX

Diagnosis

Leukaemia

Type of trial

Pharmaceutical

Type of treatement

Haematology

Phase

II

Investigators

Principal Investigator
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