- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923789
A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma
June 7, 2021 updated by: The First Affiliated Hospital of Soochow University
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
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.
Study Overview
Status
Recruiting
Detailed Description
High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation(ASCT) is still the standard salvage treatment for relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL).
However, its overall survival (OS) and event-free survival (EFS) of 3 years and above are less than 50%.
Chimeric antigen receptor T (CART) cell therapy has shown great efficacy in treating B-NHL in recent years.
Preclinical studies have indicated that the infusion of hematopoietic stem cells could promote the amplification and function of adoptive metastatic anti-tumor CD8+T cells, providing a certain theoretical basis for ASCT combined with CART cell therapy.
In order to evaluate the efficacy and safety of ASCT bridging CART cell therapy in treating R/R B-NHL, we conduct this single center, prospective cohort study.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215000
- Recruiting
- The First Affiliated Hospital of Soochow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The total number of patients was 60.
Description
Inclusion Criteria:
- Histologically confirmed B-NHL with extrinsic involvement.
- Age ≥ 18 years and ≤ 65 years.
- Measurable disease of at least 15mm(node)/10mm(extranodal)
- 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.
- Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2*10^6/kg.
- Estimated survival time ≥3 months
Exclusion Criteria:
- Having received allogeneic hematopoietic stem cell transplantation previously;
- HIV-positive;
- Active hepatitis B or C infection;
- 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.
- Patients with cardiac insufficiency:ejection fraction (EF) < 30%, NYHA standard, grade II or above
- 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)
- Female patients who are pregnant, preparing to become pregnant or lactating.
- The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ASCT Without CART
Patients who undergone ASCT successfully and did not receive CART cell infusion.
|
ASCT Bridging CART
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival(PFS)
Time Frame: up to 12 months
|
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.
|
up to 12 months
|
Overall Survival(OS)
Time Frame: up to 12 months
|
The interval from the time of ASCT to death from any cause or to the last follow-up moment.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response(DOR)
Time Frame: up to 12 months
|
DOR will be assessed from ASCT to progression,death or last follow-up.
|
up to 12 months
|
Adverse Events(AE)
Time Frame: Measured from start of treatment until 28 days after last treatment.
|
Number of participants with adverse events.
Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
|
Measured from start of treatment until 28 days after last treatment.
|
Overall Response Rate(ORR)
Time Frame: up to 12 months
|
Number of patients who achieved response after the treatment.
|
up to 12 months
|
Cumulative Recurrence Rate
Time Frame: up to 12 months
|
Cumulative number of patients who recurred after the treatment.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
June 7, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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