RecruitingPhase IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Diagnoza białaczki limfoblastycznej T-komórkowej CD38 dodatniej, która wraca po leczeniu lub nie reaguje na leczenie
  • •Wcześniejsze leczenie - co najmniej trzy cykle chemioterapii
  • •Wiek co najmniej 18 lat
  • •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-2)
  • •Wystarczająca liczba płytek krwi (≥10 000/µL) i hemoglobiny (≥7,5 g/dL)
  • •Prawidłowe funkcjonowanie wątroby i nerek
  • •Kobiiety - negatywny test ciąży
  • •Zgoda na uczestnictwo w badaniu i wykonanie wszystkich badań

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 28, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (15)

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

Augsburg, Germany

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

Berlin, Germany

Gesundheit Nord Klinikverbund Bremen gGmbH, Klinikum Bremen-Mitte, Med. Klinik I

Bremen, Germany

Klinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I

Dresden, Germany

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

Düsseldorf, Germany

University Hospital Erlangen AöR, Department of Medicine 5

Erlangen, Germany

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

Frankfurt am Main, Germany

University Hospital Hamburg-Eppendorf, Department of Medicine II

Hamburg, Germany

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

Heidelberg, Germany

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

Kiel, Germany

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

Leipzig, Germany

University Hospital München-Großhadern, Medizinische Klinik und Poliklinik III

München, Germany

University Hospital Münster, Medizinische Klinik A / KMT-Zentrum

Münster, Germany

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

Oldenburg, Germany

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

Stuttgart, Germany

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/29/2026.

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