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Roginolisib + Obinutuzumab + Venetoclax for Chronic Lymphocytic Leukemia

Not yet recruiting at 1 trial location
HP
Overseen ByHang Phan
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JB

Jennifer Brown, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for people with chronic lymphocytic leukemia (CLL) that has come back or not responded to treatment, specifically after trying a BTK inhibitor. Participants should be adults who are otherwise healthy enough for more therapy.

Inclusion Criteria

I have had at least one treatment for CLL, including a covalent BTK inhibitor.
I am willing to have bone marrow biopsies before and during treatment.
Willingness to undergo bone marrow biopsy to evaluate MRD
See 10 more

Exclusion Criteria

I have not taken venetoclax, PI3K inhibitors, or CLL therapy recently.
I have recovered from serious side effects of past cancer treatments.
I have had allergic reactions to roginolisib, venetoclax, or anti-CD20 drugs in the past 6 months.
See 14 more

What Are the Treatments Tested in This Trial?

Interventions

  • Obinutuzumab
  • Roginolisib
  • Venetoclax

Trial Overview

The study tests the safety and effectiveness of using roginolisib together with obinutuzumab, followed by venetoclax. All participants receive this combination in sequence to see how well it works and what dose is best.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Roginolisib + Obinutuzumab followed by Roginolisib + VenetoclaxExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

iOnctura

Industry Sponsor

Trials
6
Recruited
430+

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