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New treatment option for Leukemia
Official title Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
ClinicalTrials.gov ID: NCT06644183
What this study is testing
What is Roginolisib?
Roginolisib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leukemia.
Also referred to as MSC2360844A, [6-fluoro-1-(4-morpholin-4-ylmethyl-phenyl)-5,5-dioxo-4,5-dihydro-1H-5λ6-thiochro-meno[4,3-c]pyrazol-3-yl]-morpholin-4-yl-methanone hemi-fumarate, C26 H27 F N4 O5 S. 0.5 C4H4O4.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%...
- 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.
- Age ≥18 years, at the time of signing the IRB approved informed consent. Because no dosing or adverse event data are currently available on the use...
You likely can't join if
- Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months. Patients must not have had any CLL-directed...
- Patients who have received a live vaccine within 30 days of planned start of study therapy. With regards to other type of vaccines, including...
- Patients requiring ongoing treatment with chronic high dose immunosuppressants (e.g., cyclosporine) or systemic steroids \> 20 mg prednisone (or...
- History of transformation of CLL to aggressive non-Hodgkin lymphoma (Richter´s transformation or pro-lymphocytic leukaemia) which may otherwise...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception...
- Participants who are receiving any other investigational agents for this condition.
See the full eligibility criteria
Who can join
- 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...
- 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.
- Age ≥18 years, at the time of signing the IRB approved informed consent. Because no dosing or adverse event data are currently available on the use of venetoclax in combination with roginolisib in participants \<18...
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Participants must meet the following organ and marrow function as defined below:
- Platelet count ≥50 x 109/L\^\^\^
- Total bilirubin ≤ 1.5 ×institutional upper limit of normal (ULN)\
- AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN
- Creatinine clearance ≥ 60 mL/min\ \
- \^\^\^Thrombocytopenia due to marrow involvement of CLL: \> 30 x 109/L for the safety run-in, and 20 x 109/L for the assigned by chance portion of the study
- \ unless increase attributed to leukemic organ involvement, hemolysis or Gilbert's syndrome. Patients who are \< 75 years may have bilirubin of ≤ 3.0 × ULN
- \ \ calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
- Patients with clinically inactive CNS disease or treated CNS disease that is no longer symptomatic, or who need corticosteroids or anticonvulsants may be enrolled in the study. For patients who have symptoms present...
- Willingness to undergo a pre-treatment and on-treatment bone marrow to evaluate MRD.
- Willingness to use adequate contraception prior to study entry and for the duration of study participation.
- The effects of roginolisib on the developing human fetus are unknown.
- Venetoclax may cause embryo fetal harm when administered to pregnant women. Anti-CD20 targeting agents are likely to cause fetal B-cell depletion. For this reason women of child-bearing potential and men must agree to...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of roginolisib or venetoclax...
- Ability to understand and the willingness to sign a written informed consent document, which includes compliance with the requirements of this protocol.
- Eligible to receive infection prophylaxis and supportive care as per institutional guidelines.
What rules you out
- 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...
- 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...
- 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...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia or fatigue. Any irAEs from prior immunotherapy must have...
- Participants who are receiving any other investigational agents for this condition.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to roginolisib or venetoclax or their formulation components or prior anti- CD20 targeting agents more than 6 months...
- Patients with a history of systemic autoimmune disease.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A are ineligible. Moderate CYP3A inhibitors and P-gp inhibitors can be administered when venetoclax dose is reduced to...
- Because of ongoing research, regularly consulting medical reference databases is recommended. One such reference is the Website of the US-FDA: (Drug Interactions \| Relevant Regulatory Guidance and Policy Documents \|...
- As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is...
- Pregnant women are excluded from this study because venetoclax has the potential to cause embryo-fetal harm, and the potential for teratogenic or abortifacient effects with roginolisib is currently unknown. Because...
- Patients with a history of other primary malignancy are excluded when they require therapy that will interfere with the investigational treatments. Exceptions are if the natural history or treatment does not have the...
- Malignancies surgically treated with curative intent and with no known active disease present for ≥2 years before the first dose of study treatment.
- Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Surgically/adequately treated low-grade, early-stage, localized prostate cancer without evidence of disease or low risk localized prostate cancer on observation.
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- History or presence of cardiovascular disease, which in the Investigator's opinion may impact the clinical trial participation. Patients with a QTcF \> 470 msec at screening.
- History of tuberculosis treatment within the preceding two years.
- Ongoing systemic bacterial, fungal, or viral infections (including also hepatitis viral infection) at the time of initiation of study treatment (defined as requiring intravenous [IV] antimicrobial, antifungal or...
- Known Human immunodeficiency virus (HIV) infection which is treated with agents that can interfere with venetoclax due to potential drug-drug interactions or increased risk of myelotoxicity.
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the...
- Known alcohol or substance abuse.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.