Acute Lymphoblastic LeukemiaNCT02813252
Long-Term Follow-up Study for Patients Previously Treated With JCAR015
An observational study of Acute Lymphoblastic Leukemia, run by Juno Therapeutics, a Subsidiary of Celgene at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- JCAR015
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Aug 2016to 22 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients previously treated with JCAR015 in a prior clinical trial
Who may be able to join
- 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.
Who cannot join
- None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Northwestern University
Chicago, Illinois, 60611
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110-1093
About this study
Official title: Long-Term Follow-up Protocol for Subjects Treated With JCAR015
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- JCAR015
- Keywords
- long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR015
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCAR015Genetic
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.
| Study group | Role | What they receive |
|---|---|---|
| JCAR015-treated | Patients who received previous treatment with JCAR015 Receives: Genetic: JCAR015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events
Measured: Every year for up to 15 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment
Measured: Every 6 months for the first 5 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment
Measured: Every year from 5 years post-treatment to up to 15 years post-treatment
Survival
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start30 Aug 2016
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813252
- Sponsor's protocol ID
- 015002
- Status last verified
- May 2022
- First submitted
- 21 Jun 2016
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Protocol for Subjects Treated With JCAR015
- ClinicalTrials.gov ID
- NCT02813252
- Acronym / sponsor ID
- 015002
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Juno Therapeutics, a Subsidiary of CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JCAR015-treated | – | Genetic: JCAR015Patients who received previous treatment with JCAR015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated with JCAR015 in a prior clinical trial
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JCAR015No 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. | Genetic | JCAR015-treated |
Primary outcome
Proportion of patients with adverse events
Time frame: Every year for up to 15 years post-treatment
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
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
Survival
Time frame: Up to 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Juno Therapeutics, a Subsidiary of Celgene at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with adverse events (time frame: Every year for up to 15 years post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.