NCT06648889 - Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 22, 2024

Primary Completion Date

February 29, 2028

Study Completion Date

August 31, 2028

Conditions

T-ALL

Interventions

DRUG

Isatuximab

Cohort 1: All patients will receive two cycles of induction therapy with standard chemotherapy, Bortezomib and Isatuximab. Isatuximab maintenance may be administered in patients with CR until SCT, progression/relapse, unacceptable toxicity, physicians' decision to change treatment or withdrawal of consent.

DRUG

Isatuximab

Cohort 2: All patients will receive at least one cycle with Isatuximab. Each cycle will be 4 weeks in duration. Isatuximab will be administered until SCT, hematologic relapse including extramedullary, unacceptable toxicity, physicians' decision, or withdrawal of consent.

Trial Locations (14)

12203

RECRUITING

Charité Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumorimmunologyt Hämatologie, Berlin

20251

RECRUITING

University Hospital Hamburg-Eppendorf, Department of Medicine II, Hamburg

24105

RECRUITING

University Hospital Schleswig-Holstein, Campus Kiel, Medical Department II, Kiel

26135

RECRUITING

Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Onkologie und Hämatologie, Oldenburg

40225

RECRUITING

University Hospital Düsseldorf, Department of Hematology, Oncology and Clinical Immunology, Düsseldorf

48149

RECRUITING

University Hospital Münster, Medizinische Klinik A / KMT-Zentrum, Münster

60580

RECRUITING

Goethe University Hospital Frankfurt, Department of Medicine, Hematology and Oncology, Frankfurt am Main

69120

RECRUITING

University Hospital Heidelberg, Department V, Hematology, Oncology and Rheumatology, Heidelberg

70376

RECRUITING

Robert-Bosch-Krankenhaus; Abteilung für Hämatologie, Onkologie und Palliativmedizin, Stuttgart

81377

RECRUITING

University Hospital München-Großhadern, Medizinische Klinik und Poliklinik III, München

86156

RECRUITING

University Hospital Augsburg, II. Medizinischen Klinik, Hämatologie, internistische Onkologie und Hämostaseologie, Augsburg

91054

RECRUITING

University Hospital Erlangen AöR, Department of Medicine 5, Erlangen

01307

RECRUITING

Klinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I, Dresden

04103

RECRUITING

University Hospital Leipzig; Klinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Bereich Hämatologie und Zelltherapie, Leipzig