Actively Recruiting
Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-14
40
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.
CONDITIONS
Official Title
Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology or cytology using the 2022 WHO classification
- Relapsed or refractory DLBCL patients who have had at least two lines of systemic treatment
- Age between 18 and 70 years, any gender
- Presence of assessable lesions when disease recurs or is difficult to treat (lymph node diameter at least 1.0 cm or skin lesions assessable by physical exam)
- Expected lifespan longer than 3 months
- No previous transplantation treatment
- ECOG performance status score of 0 or 1
- Adequate organ function including cardiac ejection fraction of at least 50%, liver enzymes less than or equal to twice the upper normal limit, total bilirubin less than twice the upper normal limit, kidney function with creatinine clearance at least 80 mL/min and creatinine below 160 umol/L, and pulmonary function with oxygen saturation above 90% and lung function tests at least 50% predicted values
- Adequate bone marrow reserve with hemoglobin at least 9 g/dL, platelet count at least 70 x 10^9/L, neutrophils at least 1.0 x 10^9/L, or adjusted counts if bone marrow invasion is present
- Ability to understand and provide written informed consent
- Willingness to use contraception if of reproductive potential from registration until study follow-up period
You will not qualify if you...
- Previous autologous hematopoietic stem cell transplantation
- HIV infection or active hepatitis B or C
- Uncontrolled active infections
- Severe liver or kidney dysfunction with enzymes or creatinine more than three times the upper normal limit
- Organic heart disease or severe arrhythmia causing symptoms or abnormal heart function (NYHA class 2 or higher)
- Other tumors requiring treatment or intervention
- History of vascular embolism
- Pregnant or breastfeeding women
- Severe immune suppression
- Psychological conditions preventing participation or informed consent
- Investigator judgment that the subject is unlikely to complete study visits or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Z
Zhengming Jin
CONTACT
C
Changju Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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