Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer R. Brown, MD, PhD
About this trial
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)
Eligibility criteria
Qualifiers
Patients with relapsed/refractory CLL who meet iwCLL criteria for requiring treatment.
Patients with measurable disease as defined by at least one of: circulating lymphocytosis > 5000 B cells/microliter, bone marrow involvement > 30%, palpable splenomegaly or lymph nodes > 1.5 cm. Computer tomography (CT) at screening must be performed and followed every 2 cycles (1 cycle = 28 days).
Patients must have received at least two prior therapies for CLL including systemic therapy containing a covalent BTK inhibitor.
Patients willing to undergo a pre-treatment and on treatment bone marrow biopsy.
Disqualifiers
Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months. Patients must not have had any CLL-directed anticancer therapy within 5 half- lives of the therapy prior to Cycle 1 Day 1.
Patients who have received a live vaccine within 30 days of planned start of study therapy. With regards to other type of vaccines, including SARS-Co2 vaccines, these are allowed.
Patients requiring ongoing treatment with chronic high dose immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg prednisone (or equivalent) QD. For example, patients with uncontrolled autoimmune haemolytic anaemia (AIHA) or idiopathic thrombocytopenia purpura (ITP), which requires > 20 mg once daily (QD) of prednisone (or equivalent) to maintain haemoglobin levels of >8.0 g/dL or platelets > 10,000 mL without transfusion support.
History of transformation of CLL to aggressive non-Hodgkin lymphoma (Richter´s transformation or pro-lymphocytic leukaemia) which may otherwise interfere with the interpretation of the outcome of the study (including biomarker evaluation).
Trial design
Treatments tested in this trial
- Roginolisib
- Venetoclax
- Rituximab
Treatment groups
64 Participants
are divided into 4 treatment groupsSponsors and collaborators
Jennifer R. Brown, MD, PhD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov