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Trial record 1 of 1 for:    015002: Long-Term Follow-up Protocol for Subjects Treated with JCAR015
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Long-Term Follow-up Study for Patients Previously Treated With JCAR015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813252
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Juno Therapeutics, Inc.

Brief Summary:
This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Genetic: JCAR015

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-up Protocol for Subjects Treated With JCAR015
Actual Study Start Date : August 30, 2016
Estimated Primary Completion Date : September 2032
Estimated Study Completion Date : September 2032

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
JCAR015-treated
Patients who received previous treatment with JCAR015
Genetic: JCAR015
No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.




Primary Outcome Measures :
  1. Proportion of patients with adverse events [ Time Frame: Every year for up to 15 years post-treatment ]
  2. Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment [ Time Frame: Every 6 months for the first 5 years post-treatment ]
  3. Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment [ Time Frame: Every year from 5 years post-treatment to up to 15 years post-treatment ]
  4. Survival [ Time Frame: Up to 15 years ]

Biospecimen Retention:   Samples With DNA
Genomic DNA prepared from peripheral blood mononuclear cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously treated with JCAR015 in a prior clinical trial
Criteria

Inclusion criteria:

  • Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
  • Patients who have provided informed consent for the long-term follow-up study prior to study participation.

Exclusion criteria:

  • None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.

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): NCT02813252


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
University of California
San Francisco, California, United States, 94143
United States, Illinois
Robert H Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Juno Therapeutics, Inc.
Celgene Corporation
Investigators
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Study Director: Nikolaus Trede, MD, PhD JunoTherapeutics, Inc.

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Responsible Party: Juno Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02813252    
Other Study ID Numbers: 015002
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Juno Therapeutics, Inc.:
long-term follow-up
chimeric antigen receptor (CAR) T cells
JCAR015
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases