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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)

Outcome Time Frame:

2 months to 2 years

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ARD12130

NCT ID:

NCT01403636

Start Date:

October 2011

Completion Date:

July 2014

Related Keywords:

  • Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Investigational Site Number 840104Sarasota, Florida  34236
Investigational Site Number 840015Columbia, Missouri  65201-8104
Investigational Site Number 840004Boston, Massachusetts  02115
Investigational Site Number 840012San Francisco, California  94143
Investigational Site Number 840018Hot Springs, Arkansas  71913
Investigational Site Number 840006Augusta, Georgia  30912
Investigational Site Number 840011Maywood, Illinois  60153
Investigational Site Number 840013Lexington, Kentucky  40536
Investigational Site Number 840007Paducah, Kentucky  42002
Investigational Site Number 840017Lebanon, New Hampshire  03756
Investigational Site Number 840009Valhalla, New York  10595
Investigational Site Number 840014Canton, Ohio  44718
Investigational Site Number 840001Philadelphia, Pennsylvania  19111
Investigational Site Number 840002Morgantown, West Virginia  26506
Investigational Site Number 840010Kansas City, Kansas  66160-7321