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CART-19 Cells for R/R B-cell Lymphoma (CCFRRBL)

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ClinicalTrials.gov Identifier: NCT03391726
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jianda Hu, Fujian Medical University

Brief Summary:
Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B-cell Lymphoma Other: CART-19 cells Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CART-19 Cells For Patients With Relapsed or Refractory B-cell Lymphoma
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
CART-19 cells treat
Other: CART-19 cells
CART-19 cells treat



Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse events that are related to treatment [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Aged between 1-65 years
  • Patients with relapse/refractory B-cell lymphoma
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CART-19 cells.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391726


Contacts
Contact: Jianda Hu, Prof.M.D.Ph.D 86-13959169016 drjiandahu@163.com

Locations
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Jianda Hu, Prof.    86-13959169016    drjiandahu@163.com   
Contact: Ting Yang, Prof.    86-13950210357    yang.hopeting@gmail.com   
Principal Investigator: Jianda Hu, Prof.         
Sponsors and Collaborators
Fujian Medical University

Responsible Party: Jianda Hu, Director of the department of Hematology, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03391726     History of Changes
Other Study ID Numbers: CART-19-01
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin