Clinical trial · Observational
A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma
A Clinical Study to Evaluate the Efficacy and Safety of Autologous Hematopoietic Stem Cell Transplantation(ASCT) Bridging Chimeric Antigen Receptor T(CART) Cell Therapy in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
- 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)
This is a single center, prospective cohort study to to evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation(ASCT) bridging chimeric antigen receptor T (CART) cell therapy in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- ASCT Without CART
- description
- Patients who undergone ASCT successfully and did not receive CART cell infusion.
- label
- ASCT Bridging CART
- description
- Patients who undergone ASCT and received CART cell infusion sequently within 1 month. Patients with disease recurrence or progression prior to the infusion of CART cells will be excluded.
Primary outcomes (2)
- measure
- Progression-free Survival(PFS)
- timeFrame
- up to 12 months
- description
- The last follow-up of a surviving patient after ASCT to the date of relapse, disease progression, death, dependent upon which occurred first over a follow-up period of 18 months.
- measure
- Overall Survival(OS)
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed B-NHL with extrinsic involvement. 2. Age ≥ 18 years and ≤ 65 years. 3. Measurable disease of at least 15mm(node)/10mm(extranodal) 4. Meet any of the following conditions :1. After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;3. Relapsed B-NHL within 12 months after ASCT;4. After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more. 5. Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2\*10\^6/kg. 6. Estimated survival time ≥3 months Exclusion Criteria: 1. Having received allogeneic hematopoietic stem cell transplantation previously; 2. HIV-positive; 3. Active hepatitis B or C infection; 4. Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study. 5. Patients with cardiac insufficiency:ejection fraction (EF) \< 30%, NYHA standard, grade II or above 6. Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) \> 2.5 times the up, Serum Creatinine (SCR) \> 2.5mg/ dL (221μmol/L) 7. Female patients who are pregnant, preparing to become pregnant or lactating. 8. The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
References
Publications (0)
Data not yet available