A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia

A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia - M18-803

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50080

Enrollment

Registered

2019-09-10

Start date

2020-07-26

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rare & aggressive T-lymphoid malignancy T-Cell Prolymphocytic Leukemia

Interventions

All subjects will receive venetoclax orally once daily (QD) plus Ibrutinib dosed orally QD.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or female subjects, at least 18 years old, with a diagnosis of R/R T-PLL that requires treatment and suitable for oral administration of study drugs. - Subjects should meet the following disease activity criteria: an Eastern Cooperative Oncology Group performance status 1.5 × ULN) • Absolute neutrophil count > 1000/µL; • Platelet count > 50,000/µL; • Creatinine clearance >= 50 mL/minute; and • Hemoglobin > 8 g/dL.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the ORR which is defined as the proportion of subjects achieving CR, CRi, or PR as their best response (per investigator assessment) in R/R subjects.	—

Secondary

Measure	Time frame
Key secondary endpoints are as follows: • PFS • Duration of response • Time-to-progression • Overall survival • Number of eligible subjects reaching autologous or allogeneic transplant • Event-free survival • Disease Control rate	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)