Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jennifer R. Brown, MD, PhD
Study ID
NCT06644183
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roginolisib — DRUG
    Phosphoinositide 3-kinase delta inhibitor, 40 mg capsule, taken orally per protocol.
  • Venetoclax — DRUG
    B-cell lymphoma 2 inhibitor, 10, 50, and 100mg tablets, taken orally per standard of care.
  • Rituximab — DRUG
    Chimeric anti-CD 20 monoclonal antibody, single-use 10 and 50mL vials, via intravenous (into the vein) infusion per standard of care.

Study Details

This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). The names of the study drugs involved in this study are: * Roginolisib (a novel type of PI3-kinase delta inhibitor) * Venetoclax (a type of B-cell lymphoma 2 inhibitor) * Rituximab (a type of monoclonal antibody)

Key Dates

Start date
Mar 19, 2025
Status verified
Feb 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2032

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b Arm A: Venetoclax + Roginolisib + Rituximab Dose Level -1
    3+3 design to establish a Recommended Phase 2 Dose (RP2D) for Roginolisib, starting at Dose Level -1. * Baseline visit, imaging, bone marrow biopsy * CT scan every 2 cycles * Cycle 1 (5 weeks): Predetermined dose of Venetoclax 1x daily * Cycle 2: Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily and predetermined dose of Roginolisib 1 x daily --If 0 of 3 participants do not experience a dose-limiting toxicity (DLT), the study will proceed. If 1 of 3 participants experience a DLT, 3 more participants will be enrolled, and if 1 of those 6 participants experience a DLT, this is the RP2D for phase 2. If a DLT is observed in 2 of 3 or 2 of 6, the study will be stopped. * Cycles 3 through Cycle 8: Day 1 of 28 day cycle: Predetermined dose of Rituximab once * Cycles 3 through 13: Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily and predetermined dose of Roginolisib 1 x daily * End of treatment visit * Follow up visits for up to 5 years
  • Experimental: Phase 1b Arm B: Venetoclax + Roginolisib + Rituximab Dose Level 1
    * Baseline visit, imaging, bone marrow biopsy * CT scan every 2 cycles * Cycle 1 (5 weeks): Predetermined dose of Venetoclax 1x daily * Cycle 2: Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily and predetermined dose of Roginolisib 1 x daily --If 0 of 3 participants do not experience a DLT, Phase 2 will start at this dose level. If 1 of 3 participants experience a DLT, 3 more participants will be enrolled, and if 1 of those 6 participants experience a DLT, this dose level will be used for Phase 2. If a DLT is observed in 2 of those 6, de-escalate to Dose Level -1. * Cycles 3 through Cycle 8: Day 1 of 28 day cycle: Predetermined dose of Rituximab once * Cycles 3 through 13: Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily and predetermined dose of Roginolisib 1 x daily * End of treatment visit * Follow up visits for up to 5 years
  • Experimental: Phase 2 Arm A: Venetoclax + Roginolisib + Rituximab
    Participants will be randomized 1:1 and stratified by TP53 aberrant disease and by the number of prior therapies. * Baseline visit, imaging, bone marrow biopsy. * CT scan every 2 cycles. * Cycle 1 (5 weeks): Predetermined dose of Venetoclax 1x daily * Cycles 2 through 13: * Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily. * Days 1 through 28 of 28 day cycle: Predetermined dose of Roginolisib 1 x daily. * Cycles 3 through Cycle 8: --Day 1 of 28 day cycle: Predetermined dose of Rituximab once. * End of treatment visit * Follow up visits for up to 5 years
  • Active Comparator: Phase 2 Arm B: Venetoclax + Rituximab
    Participants will be randomized 1:1 and stratified by TP53 aberrant disease and by the number of prior therapies. * Baseline visit, imaging, bone marrow biopsy. * CT scan every 2 cycles. * Cycle 1 (5 weeks): Predetermined dose of Venetoclax 1x daily * Cycles 2 through 13: --Days 1 through 28 of 28 day cycle: Predetermined dose of Venetoclax 1x daily. * Cycle 3 through 8: --Day 1 of 28 day cycle: Predetermined dose of Rituximab once. * End of treatment visit * Follow up visits for up to 5 years

Primary Outcome Measure

Undetectable Minimal Residual Disease(uMRD) rate by ClonoSEQ assay [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115
Jennifer Brown, MD, PhD
[email protected]
617-632-5847
Jennifer Brown, MD, PhD (PRINCIPAL_INVESTIGATOR)

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