RecruitingPhase 2NCT06648889

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

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 (GMALL-Isatuximab)

Sponsor

Goethe University

Enrollment

28 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

T-ALL

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing isatuximab — an antibody drug that targets a protein called CD38 on cancer cells — in patients with a type of leukemia called T-cell acute lymphoblastic leukemia (T-ALL) that has come back or stopped responding to treatment. **You may be eligible if...** - You have T-ALL with CD38-positive cancer cells confirmed by testing - Your leukemia has relapsed (come back) or is refractory (did not respond) after at least three cycles of standard chemotherapy - You qualify for one of the two study groups: early relapse, late relapse, primary refractory, post-transplant relapse, or second or later relapse - You have bone marrow or blood samples available for testing **You may NOT be eligible if...** - Your leukemia does not express CD38 - Your overall health is too poor for the treatment - You have uncontrolled serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

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.

DRUGIsatuximab

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 - terminated with protocol version 3.2.

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

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NCT06648889

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