Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

February 21, 2019 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Affiliated Hospital of Academy of Military Medical Sciences ,

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

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 60 years
  • Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • CD19 negative B-cell leukemia
  • Any uncontrolled active medical disorder that would preclude participation as outlined

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: allogeneic CART-19
infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Biological: allogeneic CART-19
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of study related adverse events
Time Frame: 1 year
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: up to 24 weeks
up to 24 weeks
Overall survival
Time Frame: up to 24 weeks
up to 24 weeks
Overall response rate of allogeneic CART-19
Time Frame: up to 24 weeks
An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Collaborators

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (ESTIMATE)

June 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CART-ALL-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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