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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Sanofi-Aventis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00539682

Purpose

Primary:

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:

To characterize the global safety profile. To evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule.

To assess the potential immunogenicity of SAR3419. To assess preliminary evidence of anti-lymphoma activity in patients with evaluable disease.

Condition	Intervention	Phase
Lymphoma	Drug: SAR3419	Phase I

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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

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

Primary Outcome Measures:

Dose Limiting Toxicities [ Time Frame: Incidence of dose limiting toxicities during the initial 21-day period of treatment (Cycle 1) at a given dose-level in order to determine the MTD. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic (PK) testing [ Time Frame: Pharmacokinetic (PK) testing of SAR34 to measure the amount of study drug in the body at different time points. ] [ 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

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

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Anas Younes, MD/Professor )
Study ID Numbers:	2006-1092
Study First Received:	October 2, 2007
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00539682 History of Changes
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
CD19

Additional relevant MeSH terms:

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 25, 2009