Study of Out of Specification for Tisagenlecleucel

A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

ClinicalTrials.gov Identifier: NCT04094311

Novartis Reference Number: CCTL019B2302

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product.

Specifically, this study will evaluate the safety of tisagenlecleucel in pediatric/young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (pALL) and adult patients with r/r large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the product information for tisagenlecleucel in the respective country/region. In addition to safety, key efficacy of tisagenlecleucel that is out of specification (OOS) for commercial release will also be evaluated.

Condition 
B-cell Acute Lymphoblastic Leukemia
Diffuse Large B-cell Lymphoma
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
44 participants
Start date 
Nov 21, 2019
Completion date 
Mar 31, 2022
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Biological
Tisagenlecleucel
A single intravenous (i.v.) infusion of CAR-positive viable T cells.

Eligibility Criteria

Key inclusion criteria:

Signed informed consent/assent must be obtained for this study prior to participation in the study.
Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
OOS material has not been deemed to pose an undue safety risk to the patient.
Patient is suffering from a serious or life-threatening disease or condition.
Repeat leukapheresis is not clinically appropriate per the investigator assessment.

Key exclusion criteria:

Patients meeting any of the following criteria are not eligible for inclusion in this study:
Human immunodeficience virus (HIV) positive patients.
Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
Patients with primary central nervous system (CNS) lymphoma.
History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
Uncontrolled active infection or inflammation.
Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.
Pregnant or nursing (lactating) women.

Study Locations

Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Nishinomiya, 663 8501
Hyogo
Japan
Novartis Investigative Site
Recruiting
Sakyo Ku, 606 8507
Kyoto
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
Recruiting
Okayama-city, 700-8558
Okayama
Japan
Novartis Investigative Site
Recruiting
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8431
Tokyo
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8677
Tokyo
Japan
Novartis Investigative Site
Recruiting
Bunkyo-ku, 113-8519
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104 0045
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan
Novartis Investigative Site
Recruiting
Saitama, 330 8777
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
+81337978748
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]