B Acute Lymphoblastic LeukemiaPhase 1/2CAPTiRALLNCT05310591
Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
A Phase 1/2 study testing Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) and Nivolumab starting at day -1 in people with B Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
Trial summary
Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow/ peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the… Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse
- What is being tested?
- Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) and Nivolumab starting at day -1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 13 sitesFrance
- Study dates
- 15 Mar 2023to Mar 2027
- Phase
- Phase 1/2
- 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd relapse or later, refractory ALL).
- Patient must have a second tisagenlecleucel (Kymriah ®) product available
- Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes < 10 /mm3 and/ or < 3% of total lymphocytes (< 6 months after infusion) while still being in CR with undetectable MRD
- Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes < 10 /mm3 and/ or < 3% of total lymphocytes and a CD19+ ALL detectable disease in the marrow and/or Blood
- Life expectancy > 12 weeks.
- Karnofsky (age > 16) Lansky (age < 16) > 70 at screening.
Show all 9Show fewer
- No organ dysfunction
- Who have signed an informed consent
- Affiliation to social security or any health insurance (as a beneficiary or assignee)
Who cannot join
- Patient has received intervening therapy for leukemia after first tisagenlecleucel infusion (chemotherapy, anti leukemic immunotherapy, ITK, allogeneic HSCT).
- Patient has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Patient has known history of, or any evidence of active, non-infectious pneumonitis.
- Patient has a history of non-infectious pneumonitis that required steroid or has current pneumonitis.
- Had receive prior therapy with an anti-PD1, Anti- PDL1 or anti-PDL2 agent.
- Patient has hypersensivity to pembrolizumab/ nivolumab or one of its excipients
Show all 25Show fewer
- Patient has received a live vaccine injection within 45 days of planned start of study therapy.
- Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- Patients with Burkitt's lymphoma/leukemia
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- Prior treatment with any gene therapy product except first tisagenlecleucel (Kymriah ®) injection.
- Prior treatment with any anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy, except for patients pre-treated with blinatumomab and/or tisagenlecleucel (Kymriah®)
- Prior anti-cancer monoclonal antibody within 4 weeks before starting the study.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade1 or at baseline) from adverse events due to a previously administered agent.
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of Screening), or any uncontrolled infection at Screening.
- Human immunodeficiency virus (HIV) positive test within 8 weeks of Screening.
- Presence of grade 2 to 4 acute or extensive chronic GVHD.
- Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible.
- Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening.
- Previous or concurrent malignancy with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma
- in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study.
- A primary malignancy completely resected and in CR for ≥ 5 years
- Pregnant or lactating women (female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion)
- Patient with hypersensivity to Fludarabine and/or cyclophosphamide and/or tisagenlecleucel and/or nivolumab or one of their excipients.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
CHRU Bordeaux
Bordeaux
Marie Angoso
- Recruiting
CHRU Lille
Lille
Brigitte Nelken
- Recruiting
HCL - Lyon Sud
Lyon
Marie Balsat
- Recruiting
HCL
Lyon
Carine Halfan Domenech
- Recruiting
HCL
Lyon
Solene Remy
- Recruiting
Hôpital pour enfants - La Timone
Marseille
Michel Gerard
- Recruiting
CHU Montpellier - Hopital Arnaud de Villeneuve
Montpellier
Anne Sirvent
- Recruiting
CHU Nancy
Nancy
Cécile Pochon
- Recruiting
CHU Nantes - Hopital Mère-enfants
Nantes
Fanny Rialland
- Recruiting
Robert Debre hospital
Paris
André Baruchel
- Recruiting
Saint Louis hospital
Paris
Nicolas Boissel
- Recruiting
CHU Rouen
Rouen
Nimrod Buchbinder
- Recruiting
CHRU Strasbourg
Strasbourg
Catherine Paillard
About this study
Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow/ peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the CAR T-cells, is associated to a very high risk of relapse. A reinfusion of CTL019, even after Fludarabine-Cyclophosphamide reconditioning, frequently fails to induce further expansion as observed in UPENN studies and in the Robert Debré Hospital experience.
Non-persistence of CAR T-cells may be due to immune- mediated rejection or environment-mediated suppression of their growth. Evidence for increased PD-1 expression in CAR T-cells between infusion and peak expansion has been demonstrated in clinical samples.
Read more
Preclinical data and few clinical data support a role of PD- 1-PD-L1 blockade in improving the effectiveness of CAR T-cell therapy.
The objectives of this phase I/II study is to determine the safety, efficacy and feasibility of Nivolumab (Opdivo®)- an anti-PD1 treatment- combined to tisagenlecleucel in a cohort of relapsed or refractory B-ALL patients, aged 1-25 years old, previously treated by tisagenlecleucel (Kymriah®), with a demonstrated early loss of B-cell aplasia (within 6 months), a surrogate marker of the loss of CAR T-cells or their non- functionality.
More specifically, the main objectives are:
- In cohort 1 that includes patients with a MRD negative disease status combined to an early loss (within 6 months) of B-cell aplasia :
To determine the optimal starting time of Nivolumab (Opdivo®) in terms of safety and efficacy among 4 candidate time points (day 14, day 11, day 5, and day - 1).
- In cohort 2 that includes relapsed patients with an early loss (within 6 months) of B-cell aplasia :
To estimate the feasibility in terms of safety and efficacy of a very early start of nivolumab (day-1), prior to the reinfusion of tisagenlecleucel
- Being tested
- Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ), Nivolumab starting at day -1
- Medical subject headings
- Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) )Drug
Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy.
Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks. It will include patients with MRD negative disease status.
- Four decreasing starting times for beginning nivolumab (day 14, day 11, day 5 and day -1) will be available for testing
- Patients will be enrolled sequentially by cohorts of 3 with escalation between cohorts based only on the limiting toxicities between infusion and D28
Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response.
Nivolumab starting at day -1Drug
It will include relapsed patients. Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy.
Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks.
-nivolumab starting at day -1.
Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MRD negative disease status: Time to Event Continual Reassessment Method (TITE-CRM) | Experimental | Not described Receives: Drug: Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) |
| For relapsed patients | Experimental | Not described Receives: Drug: Nivolumab starting at day -1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with limiting-toxicities
Limiting toxicities are defined by the occurrence of either
- Related to CAR-T cells infusion: CRS or aGVH: limiting toxicity will be defined as toxicity ≥ 4 ICANs: limiting toxicity will be defined as toxicity ≥ 3 (excepted grade 3 seizure, ie focal, generalized seizure that resolves rapidly)
- Related to nivolumab: immune related myocarditis, pneumonitis, encephalitis: limiting toxicity will be defined as toxicity ≥ 4
Measured: at day 28
Efficacy assessed by Minimal residual disease (MRD) negative Complete remission (CR) and B cell aplasia.
MRD negative CR is defined by undetectable disease at a 10-4 sensitivity threshold B cell aplasia is defined by blood B lymphocytes < 10 /mm3 and/or < 3% of total lymphocytes
Measured: at 3 months
Secondary outcomes (18)
Incidence of B cell aplasia
Measured: at 6 months
Increase of B cell aplasia duration compared to the previous one observed
Measured: up to 24 months
Proportion of patients with Disease best response
Measured: up to three months
Proportion of patients with Complete remission
Measured: at 1 month
Proportion of patients with Complete remission
Measured: at 3 months
Proportion of patients with Complete remission
Measured: at 6 months
Proportion of patients with Complete remission
Measured: at 12 months
Proportion of patients with Minimal residual disease
Measured: at 1 month
Proportion of patients with Minimal residual disease
Measured: at 3 months
Proportion of patients with Minimal residual disease
Measured: at 6 months
Proportion of patients with Minimal residual disease
Measured: at 12 months
Overall survival
Measured: at one year
Overall survival
Measured: at 2 years
Event Free Survival (EFS)
Measured: at 1 year
Event Free Survival (EFS)
Measured: at 2 years
Incidence of Grade 3 adverse events
Measured: up to 2 years
Incidence of Grade 3, 4 or 5 nivolumab-related adverse events
Measured: up to 2 years
Incidence of GVHD
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B Acute Lymphoblastic LeukemiaStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT05310591
- Sponsor's protocol ID
- APHP200132
- Acronym
- CAPTiRALL
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
- ClinicalTrials.gov ID
- NCT05310591
- Acronym / sponsor ID
- CAPTiRALL / APHP200132
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Apr 2022 (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.
Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow/ peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the CAR T-cells, is associated to a very high risk of relapse. A reinfusion of CTL019, even after Fludarabine-Cyclophosphamide reconditioning, frequently fails to induce further expansion as observed in UPENN studies and in the Robert Debré Hospital experience.
Non-persistence of CAR T-cells may be due to immune- mediated rejection or environment-mediated suppression of their growth. Evidence for increased PD-1 expression in CAR T-cells between infusion and peak expansion has been demonstrated in clinical samples.
Preclinical data and few clinical data support a role of PD- 1-PD-L1 blockade in improving the effectiveness of CAR T-cell therapy.
The objectives of this phase I/II study is to determine the safety, efficacy and feasibility of Nivolumab (Opdivo®)- an anti-PD1 treatment- combined to tisagenlecleucel in a cohort of relapsed or refractory B-ALL patients, aged 1-25 years old, previously treated by tisagenlecleucel (Kymriah®), with a demonstrated early loss of B-cell aplasia (within 6 months), a surrogate marker of the loss of CAR T-cells or their non- functionality.
More specifically, the main objectives are:
- In cohort 1 that includes patients with a MRD negative disease status combined to an early loss (within 6 months) of B-cell aplasia :
To determine the optimal starting time of Nivolumab (Opdivo®) in terms of safety and efficacy among 4 candidate time points (day 14, day 11, day 5, and day - 1).
- In cohort 2 that includes relapsed patients with an early loss (within 6 months) of B-cell aplasia :
To estimate the feasibility in terms of safety and efficacy of a very early start of nivolumab (day-1), prior to the reinfusion of tisagenlecleucel
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MRD negative disease status: Time to Event Continual Reassessment Method (TITE-CRM) | Experimental | Drug: Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) |
| For relapsed patients | Experimental | Drug: Nivolumab starting at day -1 |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd relapse or later, refractory ALL).
- Patient must have a second tisagenlecleucel (Kymriah ®) product available
- Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes < 10 /mm3 and/ or < 3% of total lymphocytes (< 6 months after infusion) while still being in CR with undetectable MRD
- Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes < 10 /mm3 and/ or < 3% of total lymphocytes and a CD19+ ALL detectable disease in the marrow and/or Blood
- Life expectancy > 12 weeks.
Key exclusion criteria (25 listed)
- Patient has received intervening therapy for leukemia after first tisagenlecleucel infusion (chemotherapy, anti leukemic immunotherapy, ITK, allogeneic HSCT).
- Patient has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Patient has known history of, or any evidence of active, non-infectious pneumonitis.
- Patient has a history of non-infectious pneumonitis that required steroid or has current pneumonitis.
- Had receive prior therapy with an anti-PD1, Anti- PDL1 or anti-PDL2 agent.
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 |
|---|---|---|
| Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) )Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy. Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks. It will include patients with MRD negative disease status. 1. Four decreasing starting times for beginning nivolumab (day 14, day 11, day 5 and day -1) will be available for testing 2. Patients will be enrolled sequentially by cohorts of 3 with escalation between cohorts based only on the limiting toxicities between infusion and D28 Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response. | Drug | Patients with MRD negative disease status: Time to Event Continual Reassessment Method (TITE-CRM) |
| Nivolumab starting at day -1It will include relapsed patients. Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy. Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks. -nivolumab starting at day -1. Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response. | Drug | For relapsed patients |
Primary outcome
Proportion of patients with limiting-toxicities
Time frame: at day 28
Limiting toxicities are defined by the occurrence of either - Related to CAR-T cells infusion: CRS or aGVH: limiting toxicity will be defined as toxicity ≥ 4 ICANs: limiting toxicity will be defined as toxicity ≥ 3 (excepted grade 3 seizure, ie focal, generalized seizure that resolves rapidly) - Related to nivolumab: immune related myocarditis, pneumonitis, encephalitis: limiting toxicity will be defined as toxicity ≥ 4
Efficacy assessed by Minimal residual disease (MRD) negative Complete remission (CR) and B cell aplasia.
Time frame: at 3 months
MRD negative CR is defined by undetectable disease at a 10-4 sensitivity threshold B cell aplasia is defined by blood B lymphocytes < 10 /mm3 and/or < 3% of total lymphocytes
18 secondary outcomes
Incidence of B cell aplasia
Time frame: at 6 months
Increase of B cell aplasia duration compared to the previous one observed
Time frame: up to 24 months
Proportion of patients with Disease best response
Time frame: up to three months
Proportion of patients with Complete remission
Time frame: at 1 month
Proportion of patients with Complete remission
Time frame: at 3 months
Proportion of patients with Complete remission
Time frame: at 6 months
Proportion of patients with Complete remission
Time frame: at 12 months
Proportion of patients with Minimal residual disease
Time frame: at 1 month
Proportion of patients with Minimal residual disease
Time frame: at 3 months
Proportion of patients with Minimal residual disease
Time frame: at 6 months
Proportion of patients with Minimal residual disease
Time frame: at 12 months
Overall survival
Time frame: at one year
Overall survival
Time frame: at 2 years
Event Free Survival (EFS)
Time frame: at 1 year
Event Free Survival (EFS)
Time frame: at 2 years
Incidence of Grade 3 adverse events
Time frame: up to 2 years
Incidence of Grade 3, 4 or 5 nivolumab-related adverse events
Time frame: up to 2 years
Incidence of GVHD
Time frame: up to one year
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 29 May 2024.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
- 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) and Nivolumab starting at day -1 in people with B Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
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 9 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andre Baruchel, Pr (+331 40 03 53 88, andre.baruchel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with limiting-toxicities (time frame: at day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310591, which also lists 1 linked publication.
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 29 May 2024.