Trials / Completed
CompletedNCT04204057
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Rhizen Pharmaceuticals SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
Detailed description
Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenalisib | Tenalisib 800 mg BID, Orally |
Timeline
- Start date
- 2019-11-28
- Primary completion
- 2020-10-02
- Completion
- 2020-10-02
- First posted
- 2019-12-18
- Last updated
- 2024-08-13
- Results posted
- 2021-07-22
Locations
6 sites across 3 countries: Bulgaria, Georgia, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04204057. Inclusion in this directory is not an endorsement.