Actively Recruiting

Age: 18Years +
All Genders
ID06497452

A Prospective, Observational Study to Explore the Efficacy and Safety of Salvage Therapy With Glofitamab in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Led by The First Affiliated Hospital of Soochow University · Updated on 2024-07-11

50

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of glofitamab combined with salvage therapy in real-world settings among Chinese adults diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma. This observational study aims to gather data on how well this combination works and its safety profile in everyday clinical practice. Participants in this study will receive glofitamab as part of their salvage therapy, administered by their physicians according to local clinical guidelines and practice. The study observes patients during their treatment without assigning specific interventions, reflecting real-world use of glofitamab in managing their lymphoma. During the study, researchers will monitor patient responses using criteria for malignant lymphoma to assess the best complete response rate up to about nine months from baseline. Additional outcomes include overall response rate, duration of response, progression-free survival, event-free survival, overall survival, and time to next treatment, with follow-up extending up to approximately 24 months. Safety and efficacy data are collected to better understand treatment impact in this patient population.

CONDITIONS

Brief Title

A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with B-cell non-Hodgkin lymphoma
  • Relapsed or refractory to previous treatment
  • Planned to be treated with glofitamab
Not Eligible

You will not qualify if you...

  • Currently participating in or planning to participate in any interventional clinical trial
  • Any other reason the investigator considers the participant unsuitable for the study based on their opinion or assessment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to approximately 9 months

Participants receive glofitamab in combination with salvage therapy as part of routine clinical care, administered at the discretion of their physician.

Long-term Monitoring

Duration - Up to approximately 24 months

Participants are monitored for efficacy and safety outcomes including response rates, survival, and duration of response after treatment ends.

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

H

Haiwen Huang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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