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SAR3419 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, April 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Sanofi-Aventis
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539682
  Purpose

Primary Objective:

1. To determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as single agent every 3 weeks in patients with relapsed or refractory B-cell NHL.

Secondary Objectives:

  1. To characterize the global safety profile.
  2. To evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule.
  3. To assess the potential immunogenicity of SAR3419.
  4. To assess preliminary evidence of anti-lymphoma activity in patients with evaluable disease.

Condition Intervention Phase
Lymphoma
Drug: SAR3419
Phase I

MedlinePlus related topics:   Cancer    Lymphoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   An Open Label Multi-Dose-Escalation, Safety and Pharmacokinetic Study of SAR3419 Administered As a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to find the highest tolerable dose of SAR3419 that can be given to patients with relapsed or refractory B-cell Non-Hodgkin's lymphoma. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety, effectiveness, and pharmacokinetics of SAR34 will also be studied. Pharmacokinetic (PK) testing measures the amount of study drug in the body at different time points. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   40
Study Start Date:   October 2007
Estimated Primary Completion Date:   October 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
SAR3419
Drug: SAR3419
10 mg/m^2 IV Every 3 Weeks.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically confirmed CD19-positive non Hodgkin's lymphoma.
  • Relapsed or refractory after standard treatments and with no curative option with conventional therapy.
  • Bidimensionally measurable disease.
  • No evidence of cerebral or meningeal involvement by lymphoma.
  • Age >/= 18 years.
  • ECOG performance status 0 to 2.
  • Life expectancy of at least 3 months.
  • Signed informed consent form prior to enrollment.

Exclusion Criteria:

  • Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included).
  • Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study.
  • Previous radioimmunotherapy within 12 weeks.
  • Patient with active infections or HIV infection.
  • Known active viral hepatitis.
  • Known intolerance to infused protein products or maytansinoids (an anti-tumor medication that is a derivative of a natural plant).
  • Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study.
  • Poor bone marrow reserve as defined by absolute neutrophil count < 1.5 x 10^9/L or platelets < 100 x 10^9/L.
  • Baseline QTc interval > 500 msec (determined as the median of three EKGs done within a 30-min period) (Grade >/= 3 NCI-CTC v3.0)
  • Poor organ function as defined by one of the following: a.) Total bilirubin > 1.5 x ULN (>3 x ULN for patients with liver involvement); b.) AST, ALT > 2.5 x ULN (> 5 x ULN for patients with liver involvement); c.) Serum creatinine > 2 x ULN and/or creatinine clearance < 60 mL/min
  • Pregnant or breast-feeding women (sexually active females of childbearing potential must have a negative serum or urine pregnancy test).
  • Refused to use effective birth control methods if applicable. Women that can have children must use a medically acceptable method of birth control while participating in the study (birth control pill, intrauterine device or injection of Depo-Provera) and for at least 30 days after the last dose of study medication.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539682

Contacts
Contact: Anas Younes, MD     713-792-2860    

Locations
United States, New York
Memorial Sloan-Kettering     Recruiting
      New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic     Recruiting
      Cleveland, Ohio, United States, 44195
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Anas Younes, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi-Aventis

Investigators
Principal Investigator:     Anas Younes, MD     U.T.M.D. Anderson Cancer Center    
  More Information

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Anas Younes, MD/Professor )
Study ID Numbers:   2006-1092
First Received:   October 2, 2007
Last Updated:   April 2, 2008
ClinicalTrials.gov Identifier:   NCT00539682
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma  
Lymphoma  
B-Cell NHL  
SAR3419  

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
SARS
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2008




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