A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods.

Response was assessed by the investigator based on the T-PLL consensus criteria 2019.

Progressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below:

Group A:

• lymph nodes increase in > 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir;
• spleen increase ≥ 50% in vertical length beyond normal from baseline;
• circulating lymphocyte count increase ≥ 50% from baseline;
• appearance of a new lesion;

Group B:

• platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
• hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
• neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods.

Response was assessed by the investigator based on the T-PLL consensus criteria 2019.

Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:

Group A:

• lymph nodes increase in > 20% in SLD from nadir;
• spleen increase ≥ 50% in vertical length beyond normal from baseline;
• circulating lymphocyte count increase ≥ 50% from baseline;
• appearance of a new lesion;

Group B:

• platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
• hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
• neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods.

Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.

Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:

Group A:

• lymph nodes increase in > 20% in SLD from nadir;
• spleen increase ≥ 50% in vertical length beyond normal from baseline;
• circulating lymphocyte count increase ≥ 50% from baseline;
• appearance of a new lesion;

Group B:

• platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
• hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
• neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods.

Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.

Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:

Group A:

• lymph nodes increase in > 20% in SLD from nadir;
• spleen increase ≥ 50% in vertical length beyond normal from baseline;
• circulating lymphocyte count increase ≥ 50% from baseline;
• appearance of a new lesion;

Group B:

• platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
• hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
• neutrophils decrease of ≥ 50% from baseline due to T-PLL.

DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019.

Stable disease is defined as meeting all of the following criteria for at least 3 months:

• lymph nodes change of -29% to +20% in SLD;
• spleen change of -49% to +49% beyond normal from baseline;
• circulating lymphocyte count > 30 × 10^9 /L or change of -49% to +49%;
• platelet count change of -49% to +49%;
• hemoglobin < 11.0 g/dL or change < 50% from baseline or change < 2 g/dL;
• neutrophils change of -49% to +49%.

Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods.

Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug.

A serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome.

The Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.

The Investigator assessed the relationship of the AE to the use of study drug.