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Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma

NCT01593696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-08-31

Study results available
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Summary

Background:

\- Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the cells to attack the B-cell cancer. The cells can then be given back to the participant. This study will use T cells that have been modified to attack the cluster of differentiation 19 (CD19) protein, which is found on the surface of some B-cell cancers.

Objectives:

\- To see if anti-CD19 modified white blood cells are a safe and effective treatment for children and young adults with advanced B-cell cancer.

Eligibility:

* Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia or lymphoma) that has not responded to standard treatments.
* The leukemia or the lymphoma must have the CD19 protein.
* There must be adequate organ function.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow biopsies may be performed depending on the type of cancer.
* Participants will undergo a process where white blood cells are collected, called apheresis. These cells will be modified to contain the anti-CD19 gene.
* Participants will have 3 days of chemotherapy to prepare their immune system to accept the modified cells.
* Participants will receive an infusion of their own modified white blood cells. They will remain in the hospital until they have recovered from the treatment.
* Participants will have frequent follow-up visits to monitor the outcome of the treatment.
* If the participant benefits from the treatment, then he/she may have the option for another round of treatment.

Conditions

Interventions

BIOLOGICAL

Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR)

Cells extracted, followed by induction chemotherapy before Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) infusion (dose escalation.)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nirali N Shah, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-29
Primary Completion
2016-11-11
Completion
2017-10-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593696 on ClinicalTrials.gov