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Roginolisib Plus Obinutuzumab + Venetoclax in R/R CLL

Name: Roginolisib Plus Obinutuzumab + Venetoclax in R/R CLL — clinical trial record (NCT07847957)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 1/2

SponsorDana-Farber Cancer Institute

Started2027-01-13

View on ClinicalTrials.gov ↗

Dana-Farber Cancer Institute

287 trials monitored

See 33 trials at risk

Leukemia

2,553 trials monitored

See 134 trials at risk

Chronic Lymphocytic Leukemia (CLL)

451 trials monitored

See 32 trials at risk

This is a Phase 1b and 2, open-label, single-arm study evaluating the safety, tolerability, and efficacy of roginolisib (IOA-244) in combination with obinutuzumab followed by venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have progressed after prior Bruton Tyrosine Kinase (BTK) inhibitor therapy. The study aims to determine the maximum tolerated dose of roginolisib in combination with obinutuzumab, and to assess the rate of undetectable minimal residual disease (uMRD) after sequential therapy with roginolisib, obinutuzumab, and venetoclax.

Trial Details

NCT Number	NCT07847957
Lead Sponsor	Dana-Farber Cancer Institute Collaborators: iOnctura
Conditions	Chronic Lymphocytic Leukemia (CLL), Refractory Chronic Lymphocytic Leukemia
Enrollment	40 participants
Start Date	2027-01-13
Primary Completion	2027-04-01 (estimated)
Study Completion	2027-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-09-29