At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
Tenalisib +1 moredrug
Likely dose
Not stated in 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.
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Tenalisib and Romidepsin for T Cell Lymphoma. Completed, enrolled 33 participants across 15 sites.
Detailed Summary
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsT Cell Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMar 2019
Primary CompletionMay 2021
TodayJul 2026
First PostedDec 10, 2018
Enrollment StartMar 12, 2019
Primary CompletionMay 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.6 years ago
Interventions
Tenalisibdrug
Tenalisib, BID orally daily
Romidepsindrug
Romidepsin IV