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Study Summary
No. 2006-1092:.......Lymphoma......Anas Younes......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2006-1092
Study 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)
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Physician New Patient Referral
Name:Anas YounesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:Sanofi-Aventis
Phase of Study:Phase IReturn
Visit:
Every 21 days for IV administration. During the first 3 weeks, twice a week for
blood tests. After that, weekly for blood tests for up to 5 months. Patients
will return for follow up 6 weeks after last dose.
Treatment
Agents:
SAR3419Home Care:None
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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. 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.
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Study Objectives / Outcomes
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.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:10/02/2007
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:50
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologically confirmed CD19-positive non Hodgkin's lymphoma.

2) Relapsed or refractory after standard treatments and with no curative option with conventional therapy.

3) Bidimensionally measurable disease.

4) No evidence of cerebral or meningeal involvement by lymphoma.

5) Age >/= 18 years.

6) ECOG performance status 0 to 2.

7) Life expectancy of at least 3 months.

8) Signed informed consent form prior to enrollment.

Exclusion Criteria:1) Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included).

2) Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study.

3) Previous radioimmunotherapy within 12 weeks.

4) Patient with active infections or HIV infection.

5) Known active viral hepatitis.

6) Known intolerance to infused protein products or maytansinoids (an anti-tumor medication that is a derivative of a natural plant).

7) 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.

8) Poor bone marrow reserve as defined by absolute neutrophil count < 1.5 x 10^9/L or platelets < 100 x 10^9/L.

9) Baseline QTc interval > 500 msec (determined as the median of three EKGs done within a 30-min period) (Grade >/= 3 NCI-CTC v3.0)

10) 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

11) Pregnant or breast-feeding women (sexually active females of childbearing potential must have a negative serum or urine pregnancy test).

12) 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.

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Links
Registration Number: NCT00539682
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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