A Phase 2 interventional study of autologous hematopoietic stem cell in Diffuse Large B Cell Lymphoma, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 349 are open to participants now.
This study's planned enrollment of 18 is below the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If the patient continues to have unrelieved hematologic toxicity after CAR-T cell therapy, consider infusing a reserve of stem cells; If there is no significant recovery from myelosuppression, another stem cell infusion can be performed.
Drug: autologous hematopoietic stem cell
Intervention were given myelosuppression occurring that cannot be controlled with other drugs as judged by the investigators
1-year overall survival
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
Time frame: 1 year after CAR-T cell infusion
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: End of treatment visit (1 years after stem cell infusion)
Best objective response rate
Defined as the proportion of patients with an efficacy evaluation of complete response (CR) or partial response (PR) at any time point after infusing back CAR-T cells as a percentage of all patients, with efficacy assessed by the investigators according to the 2014 Lugano efficacy criteria
Time frame: End of treatment visit (1 years after stem cell infusion)
Best complete response rate
Defined as the proportion of patients with an efficacy evaluation of CR at any time point after infusing back CAR-T cells as a percentage of all patients, with efficacy assessed by the investigators according to the 2014 Lugano efficacy criteria
Time frame: End of treatment visit (1 years after stem cell infusion)
Time to reponse
Time from CAR-T cell infusion to the first assessment of CR or PR on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: End of treatment visit (1 years after stem cell infusion)
Duration of response
Time from the first efficacy assessment of CR or PR to the time of first disease progression on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: End of treatment visit (1 years after stem cell infusion)
Progression-free survival
Progression-free survival was defined as the time from the date of leukapheresis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: End of treatment visit (1 years after stem cell infusion)
Overall survival
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
Time frame: End of treatment visit (1 years after stem cell infusion)
Overall days of hospitalization
Defined as total number of days admitted to the hospital since being infused back for CAR-T, including days of readmission for supportive care for myelosuppression
Time frame: End of treatment visit (1 years after stem cell infusion)
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Lymphoma, Large B-Cell, Diffuse→
Ruijin Hospital