Non Hodgkin LymphomaNCT03436771
Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product
An observational study of Non Hodgkin Lymphoma and Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 2 sites in United States.
Trial summary
This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Hodgkin Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
- What is being tested?
- JCAR017 and JCARH125
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2018to 20 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial
Who may be able to join
- Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
- Patients who have provided informed consent for the long-term follow-up study
Who cannot join
- None. All patients who have previously received treatment with a Juno CAR T-cell product are eligible for this long-term follow-up study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
City of Hope
Duarte, California, 91010
About this study
Official title: Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.
- Conditions
- Non Hodgkin Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Being tested
- JCAR017, JCARH125
- Keywords
- long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR017, JCARH125
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCAR017Genetic
No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival.
JCARH125Genetic
No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival.
| Study group | Role | What they receive |
|---|---|---|
| JCAR017-treated | Patients who received previous treatment with JCAR017 Receives: Genetic: JCAR017 | |
| JCARH125-treated | Patients who received previous treatment with JCARH125 Receives: Genetic: JCARH125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events
Measured: 15 years from last treatment
Proportion of patients with detectable viral vector sequences
Measured: 15 years from last treatment
Proportion of patients with detectable RCR or RCL
Measured: 15 years from last treatment
Secondary outcomes (2)
Overall survival
Measured: 15 years from last treatment
Progression-free survival
Measured: 15 years from last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start19 Feb 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Why it stopped: Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Garcia, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436771
- Sponsor's protocol ID
- LTFU001
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
- ClinicalTrials.gov ID
- NCT03436771
- Acronym / sponsor ID
- LTFU001
- Conditions
- Non Hodgkin Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Keywords
- long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR017, JCARH125
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Juno Therapeutics, a Subsidiary of CelgeneIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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 a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JCAR017-treated | – | Genetic: JCAR017Patients who received previous treatment with JCAR017 |
| JCARH125-treated | – | Genetic: JCARH125Patients who received previous treatment with JCARH125 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial
Key inclusion criteria (2 listed)
- Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
- Patients who have provided informed consent for the long-term follow-up study
Key exclusion criteria (1 listed)
- None. All patients who have previously received treatment with a Juno CAR T-cell product 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 |
|---|---|---|
| JCAR017No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival. | Genetic | JCAR017-treated |
| JCARH125No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival. | Genetic | JCARH125-treated |
Primary outcome
Proportion of patients with adverse events
Time frame: 15 years from last treatment
Proportion of patients with detectable viral vector sequences
Time frame: 15 years from last treatment
Proportion of patients with detectable RCR or RCL
Time frame: 15 years from last treatment
2 secondary outcomes
Overall survival
Time frame: 15 years from last treatment
Progression-free survival
Time frame: 15 years from last treatment
Results and safety
The study was stopped early (reason given: Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Individual participant dataSharing planned: No
Related trials for Non Hodgkin Lymphoma
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
RecruitingObservational study
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Cutaneous T Cell Lymphoma
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
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.
Jacob Garcia, MD study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Hodgkin Lymphoma and Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 2 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: stopped early, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.). Results are not available in the source record.
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: 15 years from last treatment). The study lists 3 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 4 May 2020.