Acute Lymphoblastic LeukemiaPhase 2ISAKIDSNCT03860844
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
A Phase 2 study testing Isatuximab, Dexamethasone or equivalent and Fludarabine in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Sanofi at 41 sites in 16 countries.
Trial summary
Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: Safety and tolerability… Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Isatuximab, Dexamethasone or equivalent and Fludarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 41 sitesin 16 countries
- Study dates
- 6 Aug 2019to 26 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 28 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant 28 days to less than 18 years of age, at the time of signing the informed consent.
- Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
- Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration.
- Participants who had no more than 1 prior salvage therapy.
- White Blood Cell (WBC) counts below 20 x10^9/L on Day 1 before isatuximab administration
Who cannot join
- Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.
- Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for >2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).
- Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.
- Participants with LBL with bone marrow blasts <5%.
- Participants with Burkitt-type ALL.
- Acute leukemia with testicular or central nerve system involvement alone.
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- Participants who had developed therapy related acute leukemia.
- Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration.
- Participants with white blood cell count > 50 x10^9/L at the time of screening visit.
- Participants who had been exposed to anti-CD38 therapies within 6 months prior to Day-1.
- The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
41 sites in 16 countries.
41 sites in 16 countries
Brazil7 sites
Investigational Site Number :0760013
Curitiba, Paraná, 80250-060
Investigational Site Number :0760006
Curitiba, Paraná, 81520-060
Investigational Site Number :0760010
Jaú, São Paulo, 17210-070
Investigational Site Number :0760007
Porto Alegre, Rio Grande do Sul, 90035 003
Investigational Site Number :0760009
Ribeirão Preto, São Paulo, 14048-900
Investigational Site Number :0760001
São Paulo, São Paulo, 08270-070
Investigational Site Number :0760004
São Paulo, São Paulo, 4023-062
Argentina4 sites
Investigational Site Number :0320005
Buenos Aires, C1118AAT
Investigational Site Number :0320004
Buenos Aires, C1245AAM
Investigational Site Number :0320002
CABA, Buenos Aires, C1181ACH
Investigational Site Number :0320006
Capital Federal, Buenos Aires, C1425DUC
France4 sites
Investigational Site Number :2500002
Lille, 59037
Investigational Site Number :2500003
Lyon, 69008
Investigational Site Number :2500001
Paris, 75571
Investigational Site Number :2500004
Paris, 75935
Italy4 sites
Investigational Site Number :3800002
Genoa, Liguria, 16147
Investigational Site Number :3800001
Monza, Lombardy, 20900
Investigational Site Number :3800003
Turin, Piedmont, 10126
Investigational Site Number :3800005
Verona, Veneto, 37126
Germany3 sites
Investigational Site Number :2760005
Erlangen, 91054
Investigational Site Number :2760003
Hamburg, 20246
Investigational Site Number :2760006
Münster, 48149
Portugal3 sites
Investigational Site Number :6200002
Coimbra, 3000-602
Investigational Site Number :6200001
Lisbon, 1099-023
Investigational Site Number :6200003
Porto, 4200-162
South Korea3 sites
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number :4100002
Seoul, Seoul-teukbyeolsi, 06351
Investigational Site Number :4100004
Seoul, Seoul-teukbyeolsi, 137-701
United States2 sites
Children's Medical Center of Dallas-Site Number:8400002
Dallas, Texas, 75235
Sarah Cannon Research Institute-Site Number:8400001
Nashville, Tennessee, 37203
Mexico2 sites
Investigational Site Number :4840005
Col. Rancho Menchaca, Querétaro, 76140
Investigational Site Number :4840001
Monterrey, Nuevo León, 64460
Norway2 sites
Investigational Site Number :5780001
Bergen, 5021
Investigational Site Number :5780002
Oslo, 0342
Peru2 sites
Investigational Site Number :6040001
Arequipa
Investigational Site Number :6040002
Lima, 34
About this study
Official title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse
Primary Objective:
Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)
Secondary Objectives:
- Safety and tolerability assessments
- Assessment of infusion reactions (IRs)
- Pharmacokinetics (PK) of isatuximab
- Minimal residual disease
- Overall response rate
- Overall survival
- Event free survival
- Duration of response
- Relationship between clinical effects and CD38 receptor density and occupancy
Read the detailed description
The study included:
- a screening period of up to (up to 3 weeks prior to the first study treatment administration);
- a study treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)];
- the period of aplasia followed by a recovery period;
- an end of treatment (EOT) visit [within 30 days after hematological recovery;
- a follow-up period (until final analysis cut off date).
- Being tested
- Isatuximab, Dexamethasone or equivalent, Fludarabine, Cytarabine, Liposomal daunorubicin
- Keywords
- Anti-CD38 monoclonal antibody
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Also called SAR650984, Sarclisa
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous
Dexamethasone or equivalentDrug
Pharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral
FludarabineDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
CytarabineDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Liposomal daunorubicinDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Daunorubicin (nonliposomal)Drug
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
IdarubicinDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Filgrastim or equivalentDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
MitoxantroneDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
DoxorubicinDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
VincristineDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Pegaspargase (PEG) AsparaginaseDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
CyclophosphamideDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous
EtoposideDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
MethotrexateDrug
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
L - AsparginaseDrug
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
HydroxyureaDrug
Pharmaceutical form: Solution for injection Route of administration: PO
L - Asparaginase (Erwinase)Drug
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia | Experimental | This arm includes participants from 3 cohorts: AML, T-ALL and B-ALL.; AML: Weekly dosing of isatuximab with induction chemotherapy. The therapy may be repeated one more cycle; ALL: (Includes T-ALL and B-ALL) Weekly dosing of isatuximab with induction chemotherapy, then biweekly dosing of isatuximab with consolidation chemotherapy. Receives: Drug: Isatuximab; Drug: Dexamethasone or equivalent; Drug: Fludarabine; Drug: Cytarabine; Drug: Liposomal daunorubicin; Drug: Daunorubicin (nonliposomal); Drug: Idarubicin; Drug: Filgrastim or equivalent; Drug: Mitoxantrone; Drug: Doxorubicin; Drug: Vincristine; Drug: Pegaspargase (PEG) Asparaginase; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Methotrexate; Drug: L - Asparginase; Drug: Hydroxyurea; Drug: L - Asparaginase (Erwinase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Response (CR) Rate
The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL).
Measured: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
Secondary outcomes (15)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first.
Measured: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
Number of Participants With Infusion Reactions (IRs)
An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator.
Measured: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
Plasma samples were collected at specified timepoints to determine the AUC of isatuximab.
Measured: From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10
AML: AUC of Isatuximab
Plasma samples were collected at specified timepoints to determine the AUC of isatuximab.
Measured: From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8
B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
Measured: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
Measured: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15
B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab
Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.
Measured: At end of infusion on Cycle 1 Days 1 and 29
AML: Ceoi of Isatuximab
Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.
Measured: At end of infusion on Cycle 1 Days 1 and 15
Number of Participants With Negative Minimal Residual Disease (MRD)
MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD.
Measured: From screening until the study completion date, approximately 45 months
Overall Response Rate (ORR)
ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site.
Measured: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
Overall Survival (OS)
Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Measured: From first study treatment administration up to death due to any cause, a maximum of 45 months
Event-Free Survival (EFS)
EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Measured: From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Duration of Response (DoR)
Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Measured: From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Cluster of Differentiation (CD)38 Receptor Density
Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control.
Measured: Pre-dose on Day 1
CD38 Receptor Occupancy
Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100.
Measured: Pre-dose on Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start6 Aug 2019
- Primary completion12 Sep 2022
- Study completion26 May 2023
Why it stopped: Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860844
- Sponsor's protocol ID
- ACT15378
- Other IDs
- PIP - 2018-002697-45, U1111-1202-1096, 2018-002697-45, 2018
- Acronym
- ISAKIDS
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2019
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse
- ClinicalTrials.gov ID
- NCT03860844
- Acronym / sponsor ID
- ISAKIDS / ACT15378
- Keywords
- Anti-CD38 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)
Secondary Objectives:
- Safety and tolerability assessments
- Assessment of infusion reactions (IRs)
- Pharmacokinetics (PK) of isatuximab
- Minimal residual disease
- Overall response rate
- Overall survival
- Event free survival
- Duration of response
- Relationship between clinical effects and CD38 receptor density and occupancy
Detailed description
The study included:
- a screening period of up to (up to 3 weeks prior to the first study treatment administration);
- a study treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)];
- the period of aplasia followed by a recovery period;
- an end of treatment (EOT) visit [within 30 days after hematological recovery;
- a follow-up period (until final analysis cut off date).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia | Experimental | Drug: Isatuximab, Drug: Dexamethasone or equivalent, Drug: Fludarabine, Drug: Cytarabine, Drug: Liposomal daunorubicin, Drug: Daunorubicin (nonliposomal), Drug: Idarubicin, Drug: Filgrastim or equivalent, Drug: Mitoxantrone, Drug: Doxorubicin, Drug: Vincristine, Drug: Pegaspargase (PEG) Asparaginase, Drug: Cyclophosphamide, Drug: Etoposide, Drug: Methotrexate, Drug: L - Asparginase, Drug: Hydroxyurea, Drug: L - Asparaginase (Erwinase)This arm includes participants from 3 cohorts: AML, T-ALL and B-ALL.; AML: Weekly dosing of isatuximab with induction chemotherapy. The therapy may be repeated one more cycle; ALL: (Includes T-ALL and B-ALL) Weekly dosing of isatuximab with induction chemotherapy, then biweekly dosing of isatuximab with consolidation chemotherapy. |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant 28 days to less than 18 years of age, at the time of signing the informed consent.
- Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
- Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration.
- Participants who had no more than 1 prior salvage therapy.
- White Blood Cell (WBC) counts below 20 x10^9/L on Day 1 before isatuximab administration
Key exclusion criteria (11 listed)
- Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.
- Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for >2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).
- Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.
- Participants with LBL with bone marrow blasts <5%.
- Participants with Burkitt-type ALL.
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 |
|---|---|---|
| IsatuximabAlso: SAR650984, SarclisaPharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| Dexamethasone or equivalentPharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| FludarabinePharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| CytarabinePharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| Liposomal daunorubicinPharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| Daunorubicin (nonliposomal)Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| IdarubicinPharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| Filgrastim or equivalentPharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| MitoxantronePharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| DoxorubicinPharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| VincristinePharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| Pegaspargase (PEG) AsparaginasePharmaceutical form: Solution for injection Route of administration: Intravenous infusion | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| CyclophosphamidePharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| EtoposidePharmaceutical form: Solution for injection Route of administration: Intravenous infusion | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| MethotrexatePharmaceutical form: Solution for injection Route of administration: Intravenous infusion | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| L - AsparginasePharmaceutical form: Solution for injection Route of administration: Intramuscular | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| HydroxyureaPharmaceutical form: Solution for injection Route of administration: PO | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
| L - Asparaginase (Erwinase)Pharmaceutical form: Solution for injection Route of administration: Intramuscular | Drug | Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia |
Primary outcome
Percentage of Participants With Complete Response (CR) Rate
Time frame: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL).
15 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
Number of Participants With Infusion Reactions (IRs)
Time frame: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
Time frame: From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10
AML: AUC of Isatuximab
Time frame: From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8
B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Time frame: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Time frame: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15
B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab
Time frame: At end of infusion on Cycle 1 Days 1 and 29
AML: Ceoi of Isatuximab
Time frame: At end of infusion on Cycle 1 Days 1 and 15
Number of Participants With Negative Minimal Residual Disease (MRD)
Time frame: From screening until the study completion date, approximately 45 months
Overall Response Rate (ORR)
Time frame: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
Overall Survival (OS)
Time frame: From first study treatment administration up to death due to any cause, a maximum of 45 months
Event-Free Survival (EFS)
Time frame: From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Duration of Response (DoR)
Time frame: From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Cluster of Differentiation (CD)38 Receptor Density
Time frame: Pre-dose on Day 1
CD38 Receptor Occupancy
Time frame: Pre-dose on Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ACT15378 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
41 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Dexamethasone or equivalent and Fludarabine in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Sanofi at 41 sites in 16 countries.
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 5 inclusion and 11 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Brazil, Argentina, France, Italy, Germany and 11 more countries. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Complete Response (CR) Rate (time frame: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks). 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 9 Sep 2025.