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UNKNOWNPHASE1

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma

NCT03110640•First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Detailed Description

Primary objectives 1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

Eligibility

Age

5 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•5 Years to 70 Years, Male and female;
•Expected survival \> 12 weeks;
•Performance score 0-2;

Exclusion Criteria

•Creatinine \< 2.5 mg/dl;
•ALT/AST \< 3x normal;
•Bilirubin \< 2.0 mg/dl;
•Adequate venous access for apheresis, and no other contraindications for leukapheresis;
•Take contraceptive measures before recruit to this trial;
•Written voluntary informed consent is given.
•Patients with symptoms of central nervous system
•Accompanied by other malignant tumor
•Active hepatitis B or C, HIV infection
•Any other diseases could affect the outcome of this trial
+9 more criteria

Locations (1)

The First Affilicated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Key Dates

Start Date

October 1, 2016

Primary Completion Date

June 1, 2020

Completion Date

September 1, 2021

Last Updated

November 27, 2019

Enrollment

ESTIMATED participants

Conditions

B-cell Adult Acute Lymphoblastic LeukemiaB-cell Chronic Lymphocytic LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionHematopoietic/Lymphoid CancerRefractory Chronic Lymphocytic Leukemia

Interventions

anti-CD19 CAR-T

BIOLOGICAL

Fludarabine

DRUG

Cyclophosphamide

DRUG

Contacts

Kang Yu, M.D.

CONTACT

55578037 yukang62@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

Inclusion Criteria

Exclusion Criteria

Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

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Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

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