MDACC Study Summary 2011-0287

Study Summary
No. 2011-0287:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2011-0287

Study Title:	Phase II two stage dose finding run-in study of SAR3419, an anti-CD19 antibody-maytansine conjugate, administered as a single agent by intravenous infusion in patients with relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Physician

New Patient Referral



Name:	Hagop Kantarjian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7026 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Sanofi-Aventis

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	SAR3419	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if SAR3419 can help to control ALL. The safety of the study drug will also be studied. SAR3419 is a substance that can locate and bind to CD19, a molecule that is found on most ALL cells. This may cause the cancer cells to die.

Study Objectives / Outcomes

PRIMARY
To define the recommended dose of SAR3419 in ALL patients and to evaluate the efficacy of SAR3419 in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) as measured by objective response rate (ORR) at this selected dose.

Refractory ALL: failure to achieve complete remission (CR) with the last treatment received,
Relapsed ALL: patients who achieved CR of any duration with the last treatment and progressed before entering the study.

SECONDARY

To evaluate the global safety profile of SAR3419,
To assess the response duration (RD), to determine the progression free survival (PFS),
To evaluate the pharmacokinetic (PK) profile and the immunogenicity on all patients.
To assess MRD.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/05/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	100

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) Patients meeting criteria: • Previously treated ALL of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration. • No more than 3 prior salvage therapies. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely. • Ph+ patients failing treatment with imatinib mesylate are accepted.

2) CD19 positive disease by flow cytometry or immunohistochemistry (locally assessed); > 30% positivity.

3) Signed written informed consent.

Exclusion Criteria:

1) Age < 16 years.

2) Eastern Cooperative Group (ECOG) performance > 2.

3) Corneal abnormalities at study entry requiring local treatment, recent history of lasik surgerys.

4) Patients who received other chemotherapy. Patients must have been off previous therapy/investigational agents/radiotherapy for >4 weeks (>6 weeks for nitrosurea or mitomycine C) and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor.

5) Prior stem cell transplant in previous 4 months and/or evidence of active graft versus host disease (GVHD)

6) Known human immunodeficiency virus (HIV) positivity.

7) Active hepatitis B virus (HBV) (HBsAg, HBeAg and viral DNA positive, with absence of anti-HBe antibody) or hepatitis C virus (HCV) infection (presence of circulating anti-HCV antibodies); non-active disease that may flare up following the treatment (carriers for HBsAg with presence of HBc antibodies)

8) Known anaphylaxis to infused antibody proteins.

9) Evidence of uncontrolled infection.

10) Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study.

11) Poor organ functions as defined by one of the following: • Total bilirubin >1.5 x upper normal limit (UNL) unless Gilbert's syndrome • SGPT or SGOT >3 x UNL, unless considered due to tumor • Creatinine >1.5 UNL and if serum creatinine >UNL, calculated creatinine clearance <50 mL/min.

12) Male and female patients who are of childbearing potential with no use of an effective barrier method of birth control (eg, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy during the study treatment period and for at least 3 months following completion of study treatment. Non-childbearing is defined as >/=1 year postmenopausal or surgically sterilized).

13) Pregnant or breast-feeding female patients.

Links

Registration Number: NCT01440179
Study Information on Clinical Trials Registry (clinicaltrials.gov)