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Status:

COMPLETED

A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Lead Sponsor:

Sanofi

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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: ma...

Detailed Description

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 po...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2014

    Estimated Enrollment :

    167 Patients enrolled

    Trial Details

    Trial ID

    NCT01403636

    Start Date

    October 1 2011

    End Date

    September 1 2014

    Last Update

    March 17 2016

    Active Locations (30)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (30 locations)

    1

    Investigational Site Number 840012

    Los Angeles, California, United States, 90033

    2

    Investigational Site Number 840104

    Fort Meyers, Florida, United States, 33919

    3

    Investigational Site Number 840006

    Augusta, Georgia, United States, 30912

    4

    Investigational Site Number 840011

    Maywood, Illinois, United States, 60153