Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia

This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

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Key information

Conditions

B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

About this study

The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years;
Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian

Exclusion criteria

None

Treatment and study plan

Primary outcomes

overall survival

Time frame: 2 years

OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Qinghan Wang, master

CONTACT

[email protected]

86-13439319658

Sponsors and collaborators

Lead sponsor

Juventas Cell Therapy Ltd.

Industry

Registry information

Official study title

To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2029
First posted: Jun 10, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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