Clinical trial · Interventional
Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia
A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: \- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab Secondary Objectives: * To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL) * To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when used in combination in subjects with iNHL, MCL or CLL * To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL * To determine the antitumor activity of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Indolent Non-Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR245409 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SAR245409 + rituximab
- description
- Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously
- interventionNames
- Drug: SAR245409
- type
- EXPERIMENTAL
- label
- SAR245409 + rituximab + bendamustine (iNHL, MCL)
- description
- Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously.
- interventionNames
- Drug: SAR245409
- type
- EXPERIMENTAL
- label
- SAR245409 + rituximab+ bendamustine (CLL)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * A confirmed diagnosis of indolent non-Hodgkin lymphoma, mantle cell lymphoma or chronic lymphocytic leukemia * Evaluable disease or measurable disease * Transfusion independent * Able to take oral medication * Male and Female subjects \> 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Women of childbearing potential using adequate contraception Exclusion criteria: * Prior therapy with a PI3K, mTOR or dual PI3K/mTOR inhibitor resulting in adverse events necessitating treatment discontinuation * Eligible for a hematopoietic stem cell transplant (HSCT) * The subject has received investigational or non-investigational cytotoxic chemotherapy (i.e., cyclophosphamide), small molecule cancer therapy (i.e., imatinib), biologic cancer therapies other than rituximab (i.e., alemtuzumab, cytokines, vaccines or other monoclonal antibodies) hormonal therapy, radio- or immuno- conjugates (e.g. ibritumomab tiuxetan, tositumomab) or immunosuppressants to treat malignancy within 4 weeks prior to Cycle 1, Day 1 * Radiation therapy within 2 weeks prior to Cycle 1, Day 1 * Autologous Hematopoietic Stem Cell Transplant (HSCT) within the past 16 weeks * Prior allogeneic HSCT * Active central nervous system (CNS) metastases or leptomeningeal involvement * Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody (anti-HCV) * Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection * Active peptic ulcer disease requiring treatment with proton pump inhibitors (e.g. pantoprazole) or Type 2 histamine antagonists (e.g. cimetidine) * Diagnosis or treatment for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell or squamous cell carcinoma of the skin, an in situ malignancy or low-risk prostate cancer after curative therapy * Inadequate bone marrow function * Abnormal liver function * Abnormal renal function * Abnormal coagulation The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
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