Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL

Summary

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.

Eligibility

Inclusion Criteria:

1. Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
2. Patients with R/R DLBCL who have received at least two lines of systemic treatment;
3. Age range: 18-70 years old, male or female not limited;
4. When the disease recurs or is difficult to treat, there are assessable lesions (lymph node diameter ≥ 1.0cm; or skin lesions assessable by physical examination);
5. Expected lifespan\>3 months;
6. No previous transplantation treatment has been performed;
7. ECOG score 0-1 points;
8. Appropriate organ function:

   Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, total bilirubin\<2 times the upper limit of normal; Renal function: serum creatinine clearance rate ≥ 80 mL/min, creatinine\<160 umol/l; Pulmonary function: Without oxygen inhalation, SPO2\>90%, FEV1, FVC, and DLCO ≥ 50% predicted values;
9. Adequate bone marrow reserve is defined as:

   Hemoglobin ≥ 9g/dL, Platelet count ≥ 70 × 10 \^ 9/L, The absolute value of neutrophils is ≥ 1.0 × 10 \^ 9/L, If accompanied by bone marrow invasion, platelet count ≥ 50 × 10 \^ 9/L, absolute neutrophil count ≥ 0.75 × 10 \^ 9/L, The number of CD34+cells is ≥ 2.0 × 109/kg.
10. The patient has the ability to understand and is willing to provide written informed consent.
11. Subjects with fertility or potential for fertility must be willing to undergo contraception from the date of registration in this study until the study follow-up period.

Exclusion Criteria:

-1) Previously underwent autologous hematopoietic stem cell transplantation; 2) HIV infection and/or active hepatitis B or C; 3) Uncontrolled active infections; 4) Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal); 5) Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2); 6) Simultaneously present other tumors that require treatment or intervention; 7) Previous or current history of vascular embolism; 8) Pregnant or lactating women; 9) In a state of severe immune suppression; 10) Other psychological conditions that hinder patients from participating in research or signing informed consent forms.

11\) According to the researcher's assessment, it is unlikely that the subjects will complete all the required study visits or procedures, including follow-up visits, or meet the requirements for participation in the study.

Conditions2

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