Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04923789
Other study ID # 2020173
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 1, 2023

Study information

Verified date August 2020
Source The First Affiliated Hospital of Soochow University
Contact Caixia Li, M.D.
Phone +86 512 67781856
Email licaixia@suda.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2023
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival(PFS) 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
Primary Overall Survival(OS) The interval from the time of ASCT to death from any cause or to the last follow-up moment. up to 12 months
Secondary Duration of Response(DOR) DOR will be assessed from ASCT to progression,death or last follow-up. up to 12 months
Secondary Adverse Events(AE) 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.
Secondary Overall Response Rate(ORR) Number of patients who achieved response after the treatment. up to 12 months
Secondary Cumulative Recurrence Rate Cumulative number of patients who recurred after the treatment. up to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05420493 - Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1
Completed NCT00005803 - Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT04545762 - Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1
Active, not recruiting NCT03583424 - Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT04150913 - A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity Phase 2
Active, not recruiting NCT03213691 - Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT06026319 - CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma Phase 1
Recruiting NCT06119685 - IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers Phase 1/Phase 2
Recruiting NCT05892718 - A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors Phase 1
Active, not recruiting NCT04284774 - Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2
Active, not recruiting NCT03220035 - Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Terminated NCT02420795 - Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03778619 - MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin Phase 1/Phase 2
Active, not recruiting NCT03213678 - Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT02568553 - Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma Phase 1
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT03213665 - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT03210662 - Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Phase 2