Clinical trial · Interventional
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma
- 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 evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL) Secondary Objectives: * To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409 * To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL * To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR245409 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- mantle cell
- description
- 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
- interventionNames
- Drug: SAR245409
- type
- EXPERIMENTAL
- label
- follicular lymphoma
- description
- 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
- interventionNames
- Drug: SAR245409
- type
- EXPERIMENTAL
- label
- CLL/SLL
- description
- 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Tissue from an archived or fresh tumor sample * A peripheral blood buffy coat sample is required for CLL/SLL. * Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma * Patient \> or = 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2. Patients with DLBCL will have ECOG \< or = 1 * Adequate white blood cells and hemoglobin * Good kidney and liver function * Fasting glucose \< 160 mg/dL * No other malignancy * Use of adequate birth control Exclusion criteria: * Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment * Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment * Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication. * Radiation therapy within 2 weeks of enrollment * Autologous stem cell transplantation within 16 weeks of enrollment * Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion criteria * Central nervous system (CNS) or leptomeningeal involvement. Patients with DLBCL may have active CNS or leptomeningeal involvement. * Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology * Primary CNS lymphoma * Primary mediastinal B-lymphoma The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDBrown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. PMID 29550382