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SARCLISA 20mg/mL concentrate for solution for infusion.

DRUG14 trials

Sponsors

Sanofi-Aventis Recherche & Developpement, Goethe University Frankfurt, University Medical Center Hamburg-Eppendorf, Assistance Publique Hopitaux De Paris, Emn Trial Office S.r.l. Impresa Sociale

Conditions

AL AmyloidosisCancerCytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemiaIsatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)Multiple MyelomaMultiple myelomaNewly diagnosed Non-Frail transplant Ineligible Multiple Myeloma elderly patientsNewly diagnosed transplant ineligible multiple myeloma

Phase 2

International, multi-center, open-label, treatment extension study in patients with multiple myeloma who are still benefitting from isatuximab-based therapy following completion of a Phase 1, 2, or 3 parental study
Active, not recruitingCTIS2023-507180-19-00
Sanofi-Aventis Recherche & DeveloppementCancer
Start: 2023-04-05Target: 37Updated: 2025-12-01
A multicenter, single-arm phase II study to assess the safety, tolerability, and efficacy of Isatuximab in adult patients with cytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia
RecruitingCTIS2023-507899-47-00
Goethe University FrankfurtCytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia
Start: 2024-10-22Target: 40Updated: 2025-12-08
Isatuximab and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma Patients (Isabel study)
Active, not recruitingCTIS2024-513397-21-00
Emn Trial Office S.r.l. Impresa SocialeRelapsed Multiple Myeloma
Start: 2021-09-16Target: 25Updated: 2025-10-27
ErythroSIM : Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of PCRA by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
RecruitingCTIS2024-514351-14-00
Assistance Publique Hopitaux De ParisPure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
Start: 2023-02-20Target: 90Updated: 2025-10-28
ISKPD-IFM2018-03-Multicenter Open label Phase 2 study of Isatuximab plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma
CompletedCTIS2024-516670-29-00
Centre Hospitalier Universitaire De PoitiersMultiple Myeloma
Start: 2020-09-15End: 2025-09-26Target: 90Updated: 2025-06-02
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients _ GMMG-CONCEPT
Active, not recruitingCTIS2024-511791-32-00
University Medical Center Hamburg-EppendorfMultiple Myeloma
Start: 2017-08-15Target: 246Updated: 2025-10-06
An open, randomised, controlled phase II trial of CellProtect in combination with Isatuximab antibody versus Isatuximab antibody alone as maintenance treatment in patients with Multiple Myeloma undergoing high dose treatment (ISA-HC-NK)
Active, not recruitingCTIS2024-514527-42-00
Karolinska Institutet, Karolinska InstitutetMultiple myeloma
Start: 2023-07-28Target: 62Updated: 2024-09-26
Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
Active, not recruitingCTIS2024-515581-13-00
Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbHIsatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
Start: 2021-10-20Target: 138Updated: 2025-10-27
GRAALL 2024 - A 3-cohort Randomized Study evaluating the role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults with Acute Lymphoblastic Leukemia
RecruitingCTIS2024-511437-35-00
Assistance Publique Hopitaux De ParisPatients aged 18-65 years old with newly diagnosed previously untreated ALL or T-LL.
Start: 2026-01-05Target: 1100Updated: 2025-11-20
ISASOCUT-IFM2022-05-Multicenter phase 2 study of subcutaneous isatuximab plus bortezomib, lenalidomide and dexamethasone in the treatment of newly diagnosed transplant ineligible multiple myeloma
RecruitingCTIS2024-517099-39-00
Centre Hospitalier Universitaire De PoitiersNewly diagnosed transplant ineligible multiple myeloma
Start: 2024-11-18Target: 74Updated: 2025-09-29
A phase 2, open label, multicenter, single-stage study to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy
Not yet recruitingCTIS2024-513887-25-00
Intergroupe Francophone Du MyelomeAL Amyloidosis
Target: 30Updated: 2025-12-19

Phase 3