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BESPONSA 1 mg powder for concentrate for solution for infusion

DRUG5 trials

Sponsors

Karolinska University Hospital, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Pfizer Inc., Fondazione Gimema Franco Mandelli Onlus, Fundacion PETHEMA

Conditions

Acute B-cell Lymphoblastic Leukemia with minimal residual positive disease prior to haematopoietic stem cell transplantation in adult patientsAcute Lymphoblastic LeukaemiaAcute Lymphoblastic Leukemia (ALL)Acute lymphoblastic leukaemiapediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

Phase 1

Phase 2

B1931036 - A prospective, randomized, open-label phase 2 study to evaluate the superiority of Inotuzumab Ozogamicin monotherapy versus ALLR3 for induction treatment of childhood high risk first relapse B-cell precursor Acute Lymphoblastic Leukaemia
RecruitingCTIS2023-509810-13-00
Pfizer Inc.Acute Lymphoblastic Leukemia (ALL)
Start: 2023-05-13Target: 94Updated: 2025-10-27
ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) with Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)
RecruitingCTIS2022-501050-11-01
Karolinska University HospitalAcute Lymphoblastic Leukaemia
Start: 2020-07-13Target: 5943Updated: 2025-12-17
A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients with B-Cell Acute Lymphoblastic Leukemia with positive Minimal Residual Disease before any Hematopoietic Stem Cell Transplantation. ALL2418
RecruitingCTIS2023-510516-39-00
Fondazione Gimema Franco Mandelli OnlusAcute B-cell Lymphoblastic Leukemia with minimal residual positive disease prior to haematopoietic stem cell transplantation in adult patients
Start: 2019-10-30Target: 76Updated: 2024-12-03
Multicenter, open label, phase II clinical trial of inotuzumab ozogamicin as prophylaxis for relapse in patients with high-risk acute B-cell precursor acute lymphoblastic leukaemia after allogeneic stem cell haemotopoietic transplantation
Not yet recruitingCTIS2026-525964-17-00
Fundacion PETHEMAAcute lymphoblastic leukaemia
Target: 30Updated: 2026-09-15

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