Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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.
You may not be if
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
Clareo Health | A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
