Acute Lymphoblastic LeukemiaNCT04158011
A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells
An observational study of Acute Lymphoblastic Leukemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Nov 2019to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective review of patients with CNS - involvement of B-cell ALL, treated with CAR T cells targeting CD19 of either an institutional-based clinical trial, a pharma-based clinical trial or commercial product.
Who may be able to join
- Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system
- Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARs for CNS-Leukemia Relapse: A Retrospective International Study
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.
Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- CAR T cells, CNS leukemia
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CNS ALL at lymphodepletion | Patients with active CNS leukemia at the time of lymphodepletion | |
| CNS ALL at inclusion | Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis
Measured: 6 months
Secondary outcomes (3)
Incidence of CAR-related CRS or ICANS per ASCTC guidelines
Number of patients and average grade of cytokine-release syndrome and immune-effector cell associated neurotoxicity syndrome within 2 months after CAR treatment, according to ASCTC guidelines (Lee et al, BBMT 2019)
Measured: 2 months
Leukemia-free survival
Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis
Measured: 6 months
CNS-leukemia free survival
Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start6 Nov 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
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.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elad Jacoby, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158011
- Sponsor's protocol ID
- SMC 6257-19
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARs for CNS-Leukemia Relapse: A Retrospective International Study
- ClinicalTrials.gov ID
- NCT04158011
- Acronym / sponsor ID
- SMC 6257-19
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- CAR T cells, CNS leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 8 Nov 2019 (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.
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.
Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNS ALL at lymphodepletion | – | –Patients with active CNS leukemia at the time of lymphodepletion |
| CNS ALL at inclusion | – | –Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective review of patients with CNS - involvement of B-cell ALL, treated with CAR T cells targeting CD19 of either an institutional-based clinical trial, a pharma-based clinical trial or commercial product.
Key inclusion criteria (2 listed)
- Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system
- Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 6 months
Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis
3 secondary outcomes
Incidence of CAR-related CRS or ICANS per ASCTC guidelines
Time frame: 2 months
Leukemia-free survival
Time frame: 6 months
CNS-leukemia free survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Sheba Medical Center at 1 site in Israel.
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 0 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: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
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?
Overall survival (time frame: 6 months). 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 8 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.