CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Tenalisibdrug
Likely dose
Tenalisib 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04204057
NCT04204057Phase 2Completed

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)

Rhizen Pharmaceuticals SA·interventional·Posted Dec 18, 2019·Updated Aug 13, 2024

In Brief

A Phase 2 clinical trial evaluating Tenalisib for Leukemia, Lymphocytic, Chronic, B-Cell. Completed, enrolled 21 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Georgia, Poland
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 18, 2019
Enrollment StartNov 28, 2019
Primary CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.5 years ago

Interventions

Tenalisibdrug

Tenalisib 800 mg BID, Orally