Hematologic DiseasesBIOCART-HMNCT04209829
Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
An observational study of Hematologic Diseases, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hematologic Diseases
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Mar 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hematological malignancy
Who may be able to join
- patient with hematological malignancy (lymphoma, ALL, MM)
- patient integrated into a CAR-T Cells program treatment
- patient aged 15 years or over
- patient having signed a written consent; as well as his legal representative if <18 years old
Who cannot join
- patient with other hematological malignancies than lymphoma, LAL or MM
- patient's weight <58 kg
- patient treated with another treatment than CAR-T Cells
- patient under tutorship or curatorship
- patient not covered by a health system
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.
The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies
- Conditions
- Hematologic Diseases
- Medical subject headings
- Hematologic Diseases
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 |
|---|---|---|
| Patients with haematological malignancy | Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 90 days after (CAR)-T cell therapy initiation
Secondary outcomes (25)
Overall Survival rate
Measured: 1 year
Objective response rate
Measured: 30 days
Objective response rate
Measured: 90 days
Objective response rate
Measured: 1 year
Objective response rate
Measured: 2 years
Objective response rate
Measured: 5 years
Objective response rate
Measured: 10 years
Progression-free survival
Measured: at 1 year
Incidence of adverse events
Measured: at 30 days
Incidence of adverse events
Measured: at 90 days
Incidence of adverse events
Measured: at 1 year
Incidence of adverse events
Measured: at 2 years
Incidence of adverse events
Measured: at 5 years
Incidence of adverse events
Measured: at 10 years
Proportion of patients with an admission in intensive care
Measured: at 30 days
Proportion of patients with an admission in intensive care
Measured: at 90 days
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 30 days
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 90 days
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical, cognitive examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 6 months
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 2 years
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 5 years
Severity of neurological toxicities
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: at 10 years
Proportion of patients with a cytokine release syndrome
Cytokine release syndrome will be assessed by CTCAE v5.0
Measured: at baseline
Proportion of patients with a cytokine release syndrome
Cytokine release syndrome will be assessed by CTCAE v5.0
Measured: at 7 days
Proportion of patients with a cytokine release syndrome
Cytokine release syndrome will be assessed by CTCAE v5.0
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209829
- Sponsor's protocol ID
- APHP190678
- Acronym
- BIOCART-HM
- Status last verified
- Oct 2019
- First submitted
- 22 Nov 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
- ClinicalTrials.gov ID
- NCT04209829
- Acronym / sponsor ID
- BIOCART-HM / APHP190678
- Conditions
- Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2035 (estimated)
- First posted
- 24 Dec 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.
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.
The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haematological malignancy | – | –Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematological malignancy
Key inclusion criteria (4 listed)
- patient with hematological malignancy (lymphoma, ALL, MM)
- patient integrated into a CAR-T Cells program treatment
- patient aged 15 years or over
- patient having signed a written consent; as well as his legal representative if <18 years old
Key exclusion criteria (5 listed)
- patient with other hematological malignancies than lymphoma, LAL or MM
- patient's weight <58 kg
- patient treated with another treatment than CAR-T Cells
- patient under tutorship or curatorship
- patient not covered by a health system
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
Complete response rate
Time frame: 90 days after (CAR)-T cell therapy initiation
25 secondary outcomes
Overall Survival rate
Time frame: 1 year
Objective response rate
Time frame: 30 days
Objective response rate
Time frame: 90 days
Objective response rate
Time frame: 1 year
Objective response rate
Time frame: 2 years
Objective response rate
Time frame: 5 years
Objective response rate
Time frame: 10 years
Progression-free survival
Time frame: at 1 year
Incidence of adverse events
Time frame: at 30 days
Incidence of adverse events
Time frame: at 90 days
Incidence of adverse events
Time frame: at 1 year
Incidence of adverse events
Time frame: at 2 years
Incidence of adverse events
Time frame: at 5 years
Incidence of adverse events
Time frame: at 10 years
Proportion of patients with an admission in intensive care
Time frame: at 30 days
Proportion of patients with an admission in intensive care
Time frame: at 90 days
Severity of neurological toxicities
Time frame: at 30 days
Severity of neurological toxicities
Time frame: at 90 days
Severity of neurological toxicities
Time frame: at 6 months
Severity of neurological toxicities
Time frame: at 2 years
Severity of neurological toxicities
Time frame: at 5 years
Severity of neurological toxicities
Time frame: at 10 years
Proportion of patients with a cytokine release syndrome
Time frame: at baseline
Proportion of patients with a cytokine release syndrome
Time frame: at 7 days
Proportion of patients with a cytokine release syndrome
Time frame: at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases, run by Assistance Publique - Hôpitaux de Paris.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Thieblemont (+331 42 49 92 36, catherine.thieblemont@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 90 days after (CAR)-T cell therapy initiation). 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 24 Dec 2019.