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NCT Number: NCT06656234

The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location contact

Weili Zhao

CONTACT

[email protected]

008602164370045

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be diagnosed as R/R DLBCL
  • Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.

Exclusion criteria

  • Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Treatment and study plan

Glofitamab

Drug

Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.

Obinutuzumab

Drug

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Primary outcomes

  1. Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Time frame: Baseline up to end of study (EOS) (approximately 48 months)

Secondary outcomes

  1. Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Time frame: Baseline up to EOS (approximately 48 months)

  2. Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Time frame: Baseline up to EOS (approximately 48 months)

  3. Duration of Response (DoR)

    Time frame: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)

  4. Duration of Complete Response (DoCR)

    Time frame: From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)

  5. Time to Next Treatment (TTNT)

    Time frame: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)

  6. Overall Survival (OS)

    Time frame: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)

Study contacts

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

Weili Zhao

CONTACT

[email protected]

008602164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 24, 2024
Registry last updated
Oct 24, 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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