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Study of Out of Specification for Tisagenlecleucel

NCT ID: NCT04094311

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2026-03-31

Brief Summary

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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 CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.

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Detailed Description

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This is a single-arm, open-label, multicenter, interventional Phase IIIb study 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 for Part 1 and and r/r ALL and r/r non-Hodgkin's lymphomas (NHL) for Part 2

Patients whose final manufactured tisagenlecleucel patient-specific batch does not meet the approved local commercial release specifications are eligible for inclusion. Each case will be individually assessed and approved by the Novartis manufacturing facility and the Novartis global medical team (including Patient Safety). Following a single infusion of CTL019, the patient will be followed for 3 months for Part 1, and 1 day for Part 2.

Conditions

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B-cell Acute Lymphoblastic Leukemia Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: pALL

Pediatric/young adult patients with r/r pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.

Group Type EXPERIMENTAL

CTL019

Intervention Type BIOLOGICAL

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

Group B: r/r LBCL

Adult patients with r/r LBCL including 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 package insert for CTL019 in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.

Group Type EXPERIMENTAL

CTL019

Intervention Type BIOLOGICAL

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

Group C: r/r NHL

Adult patients with r/r NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.

Group Type EXPERIMENTAL

CTL019

Intervention Type BIOLOGICAL

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

Interventions

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CTL019

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Tisagenlecleucel

Eligibility Criteria

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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.

Exclusion Criteria

For part 1, 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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status COMPLETED

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status WITHDRAWN

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status COMPLETED

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status COMPLETED

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status WITHDRAWN

Novartis Investigative Site

Québec, Quebec, Canada

Site Status WITHDRAWN

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Tōon, Ehime, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Gifu, Gifu, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Site Status RECRUITING

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status RECRUITING

Novartis Investigative Site

Tsu, Mie-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status RECRUITING

Novartis Investigative Site

Matsumoto, Nagano, Japan

Site Status RECRUITING

Novartis Investigative Site

Nagasaki, Nagasaki, Japan

Site Status RECRUITING

Novartis Investigative Site

Yufu, Oita Prefecture, Japan

Site Status RECRUITING

Novartis Investigative Site

Kurashiki, Okayama-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Izumi, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Izumisano, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Ōsaka-sayama, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Suita, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Izumo, Shimane, Japan

Site Status RECRUITING

Novartis Investigative Site

Hamamatsu, Shizuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Fuchū, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Aomori, , Japan

Site Status RECRUITING

Novartis Investigative Site

Chiba, , Japan

Site Status RECRUITING

Novartis Investigative Site

Hiroshima, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kumamoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Niigata, , Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status RECRUITING

Novartis Investigative Site

Saitama, , Japan

Site Status RECRUITING

Novartis Investigative Site

Wakayama, , Japan

Site Status RECRUITING

Countries

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Canada Japan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

[email protected]
+41613241111

Novartis Pharmaceuticals

Role: CONTACT

+81337978748

Other Identifiers

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CCTL019B2302

Identifier Type: -

Identifier Source: org_study_id

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