Acute Myeloid LeukemiaPhase 2/3NCT04257175
CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression
A Phase 2/3 study testing CAR-T CD19 in people with Acute Myeloid Leukemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CAR-T CD19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Feb 2020to 1 Dec 2024
- Phase
- Phase 2/3
- 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
Who may be able to join
- Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .
Who cannot join
- Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
- Active involvement of CNS
- Active infection
- Pregnancy or lactation
- Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
- A positive result for the HIV infection (serum)
Show all 10Show fewer
- Active hepatitis infection
- Life-threatening allergies to cyclophosphamide or fludarabine
- No informed consent signed by candidate
- Candidate enrolled in other study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 57261
Arnon Nagler, M.D.
M.D.
About this study
Official title: Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression
Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.
However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.
The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CAR-T CD19
- Keywords
- Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T CD19Biological
The CAR-T infusion will be given in IV infusion. The target dose is 1 X 106 positive CAR / kg T cells (range: 0.5-1.5X 106 CAR / kg positive T cells).
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide, Flodarabine,CAR-T cells | Experimental | The appropriate participants will undergo lymhopheresis to collect lymphocytes from PBMC peripheral blood. CAR T CD19 cells will be produced. The participants will receive cyclophosphamide 300 mg / m² and flodarabine 30 mg / m² lymphodeplition intravenously daily for 3 days.
The CAR-T CD19 cells will be given on the 5 to 7 day post lymphodeplition . Receives: Biological: CAR-T CD19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the peripheral blood counts and differential
Will be evaluated by Coulter counter
Measured: Within two years from the introduction of the CAR-T CD19
The change in the antigen expression on the leukemic blasts
Will be evaluated by FACS
Measured: Within two years from the introduction of the CAR-T CD19
The change in the measurable residual disease
Will be evaluated by PCR
Measured: Within two years from the introduction of the CAR-T CD19
The change in the chromosomal translocations and aberrations
Will be evaluated by cytogenetics and FISH
Measured: Within two years from the introduction of the CAR-T CD19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start18 Feb 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof Arnon Nagler, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257175
- Sponsor's protocol ID
- 6482-19-SMC
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression
- ClinicalTrials.gov ID
- NCT04257175
- Acronym / sponsor ID
- 6482-19-SMC
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Feb 2020 (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.
Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.
However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.
The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide, Flodarabine,CAR-T cells | Experimental | Biological: CAR-T CD19The appropriate participants will undergo lymhopheresis to collect lymphocytes from PBMC peripheral blood. CAR T CD19 cells will be produced. The participants will receive cyclophosphamide 300 mg / m² and flodarabine 30 mg / m² lymphodeplition intravenously daily for 3 days. The CAR-T CD19 cells will be given on the 5 to 7 day post lymphodeplition . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .
Key exclusion criteria (10 listed)
- Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
- Active involvement of CNS
- Active infection
- Pregnancy or lactation
- Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
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 |
|---|---|---|
| CAR-T CD19The CAR-T infusion will be given in IV infusion. The target dose is 1 X 106 positive CAR / kg T cells (range: 0.5-1.5X 106 CAR / kg positive T cells). | Biological | Cyclophosphamide, Flodarabine,CAR-T cells |
Primary outcome
The change in the peripheral blood counts and differential
Time frame: Within two years from the introduction of the CAR-T CD19
Will be evaluated by Coulter counter
The change in the antigen expression on the leukemic blasts
Time frame: Within two years from the introduction of the CAR-T CD19
Will be evaluated by FACS
The change in the measurable residual disease
Time frame: Within two years from the introduction of the CAR-T CD19
Will be evaluated by PCR
The change in the chromosomal translocations and aberrations
Time frame: Within two years from the introduction of the CAR-T CD19
Will be evaluated by cytogenetics and FISH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CAR-T CD19 in people with Acute Myeloid 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 1 inclusion and 10 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 28 Nov 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Arnon Nagler, MD (+972-3-530 5830, Arnon.Nagler@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the peripheral blood counts and differential (time frame: Within two years from the introduction of the CAR-T CD19). 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 28 Nov 2023.