Actively Recruiting
Phase 1/2 Study of Roginolisib with Venetoclax and Rituximab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia
Led by Jennifer R. Brown, MD, PhD · Updated on 2026-02-11
64
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
J
Jennifer R. Brown, MD, PhD
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anticancer effects of combining three drugs—Roginolisib, Venetoclax, and Rituximab—in adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). This Phase 1/2, open-label, randomized study aims to see if adding Roginolisib to the standard two-drug combination of Venetoclax and Rituximab results in deeper responses. The study is supported by iOnctura SA and the U.S. Department of Defense and involves participants who have previously received at least two therapies including a BTK inhibitor. The study includes a Phase 1b safety lead-in to determine the best dose of Roginolisib with Venetoclax and Rituximab, followed by a Phase 2 randomized portion where participants are assigned to either the three-drug combination or the standard two-drug treatment. Treatments involve daily oral doses of Roginolisib and Venetoclax, with Rituximab given intravenously once per cycle during certain cycles. Participants undergo regular imaging and bone marrow biopsies to monitor disease and treatment effects. Participants will receive treatment for about 12 months and be followed for up to 5 years. Study activities include blood and urine tests, electrocardiograms, CT and MRI scans, and bone marrow biopsies before and during treatment. Researchers will measure outcomes such as the rate of undetectable minimal residual disease after one year and monitor side effects over time. Follow-up visits will continue to assess long-term response and survival.
CONDITIONS
Brief Title
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older.
- Diagnosed with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) requiring treatment.
- Measurable disease with at least one of: circulating lymphocytosis > 5000 B cells/microliter, bone marrow involvement > 30%, or palpable splenomegaly or lymph nodes > 1.5 cm.
- Received at least two prior therapies for CLL, including a covalent BTK inhibitor.
- Willing to undergo pre-treatment and on-treatment bone marrow biopsies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Adequate organ and marrow function including platelet count ≥ 50 x 10^9/L, total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST/ALT ≤ 3 times ULN, and creatinine clearance ≥ 60 mL/min.
- Willingness to use adequate contraception during study participation.
- Ability to understand and sign informed consent.
- Eligible for infection prophylaxis and supportive care as per guidelines.
You will not qualify if you...
- Prior treatment with venetoclax or PI3K inhibitors within the last 6 months.
- Received any CLL anticancer therapy within five half-lives of study start.
- Received a live vaccine within 30 days before starting study therapy.
- Ongoing treatment with high-dose immunosuppressants or systemic steroids over 20 mg prednisone daily.
- History of transformation of CLL to aggressive lymphoma or pro-lymphocytic leukemia.
- Unresolved adverse events from prior cancer therapy greater than Grade 1.
- Receiving other investigational agents for CLL.
- Allergic reactions to roginolisib, venetoclax, rituximab or similar agents within 6 months before study.
- History of systemic autoimmune disease.
- Use of strong CYP3A inhibitors or inducers unless venetoclax dose is adjusted.
- Pregnant or breastfeeding women.
- History of other malignancies requiring interfering therapy unless disease-free for 2 or more years or low-risk cancers.
- Inability to swallow oral medications.
- Cardiovascular disease that may affect participation or QTcF > 470 msec.
- History of tuberculosis treatment within 2 years.
- Active systemic infections requiring intravenous antimicrobial therapy.
- Known HIV infection with interfering treatments.
- Any serious uncontrolled medical disorder or active infection increasing risk or impairing ability to receive therapy.
- Known alcohol or substance abuse.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments including blood tests, urine tests, ECGs, imaging, and bone marrow biopsy
Duration - Approximately 12 months
Participants receive study treatment with combinations of Roginolisib, Venetoclax, and Rituximab according to their assigned arm for approximately 12 months.
Baseline visit, CT scans every 2 cycles, bone marrow biopsies, and regular treatment visits with oral drugs daily and intravenous infusions as scheduled
Duration - Up to 5 years
Participants are followed for safety and disease status for up to 5 years after treatment ends.
Periodic follow-up visits for monitoring health status and disease progression
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
H
Hang Phan, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here