Clinical trial · Interventional
Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL
A Prospective Study of Glofitamab Bridging Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma.
NCT06682130CI-TRIAL-00092090ASCT DLBCLrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma(DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A:Patients with PR or ctDNA positivity after salvage treatment | Drug | — | UNRESOLVED |
| Group B: Patients with CR and ctDNA negative after salvage treatment | Procedure | — | UNRESOLVED |
| Group C: Patients with SD/PD after posterior treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Glofitamab bridging ASCT Regimen
- description
- After at least second-line treatment, patients will be divided into three groups based on their disease status: Group A includes patients with partial response (PR) or ctDNA positivity who plan to receive ASCT or Glofitamab (specification: 10 mg per tube; dosage: 2.5 mg on day 8) as a bridge to ASCT; Group B includes patients with complete response (CR) and ctDNA negativity who will proceed directly to ASCT; Group C includes patients with stable or progressive disease (SD/PD) who will be assessed after two cycles of Glofitamab (Specification: 10mg per tube;Dosage: cycle 1: 2.5mg d8;10mg d15;cycle 2: 30mg d21). Those achieving PR will undergo ASCT, those with CR can choose ASCT or continue Glofitamab, and those with SD/PD will be removed from the group.
- interventionNames
- Drug: Group A:Patients with PR or ctDNA positivity after salvage treatment
- Procedure: Group B: Patients with CR and ctDNA negative after salvage treatment
- Drug: Group C: Patients with SD/PD after posterior treatment
Primary outcomes (1)
- measure
- Complete remission rate(CRR)
- timeFrame
- At the end of 3 months after ASCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.