A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma

NCT04923789 | Unknown

• 1 other identifier: 2020173
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Duration of Response(DOR)

  up to 12 months

• Adverse Events(AE)

  Measured from start of treatment until 28 days after last treatment.

• Overall Response Rate(ORR)

  up to 12 months

• Cumulative Recurrence Rate

  up to 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The total number of patients was 60.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Depei Wu

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D.

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Jia Chen, M.D.

CONTACT

+86 512 67781856; chenjiasuzhou@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: September 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 11, 2021

Record last verified: 2020-08

Locations

CN (1)