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Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06648889•Goethe University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- Patients with CD38 positive T-ALL fitting either to the definitions for cohort 1 or cohort 2:
•Cohort 1: In relapse or with primary refractory disease defined as ≥5% blasts in bone marrow after at least three chemotherapy cycles (induction I-II, consolidation I) with the following additional specifications:
•early relapse within 12 months from first achievement of CR or
•late relapse later than 12 months from first achievement of CR or
•primary refractory disease without any CR or
•any relapse after stem cell transplantation or
•any refractory relapse, defined as no response to at least one salvage therapy or
•any second or later relapse and
•Availability of patient material with blast cells (bone marrow or peripheral blood) for central MRD assessment or availability of respective predefined marker.
•Cohort 2: In complete hematological remission (defined as less than 5% blasts in bone marrow and no evidence of extramedullary disease) after at least three chemotherapy cycles (induction I-II, consolidation I)
+32 more criteria

Exclusion Criteria

•Extramedullary involvement except for non-bulky (\<7.5 cm) lymph node involvement, splenomegaly, or hepatomegaly
•Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment
•Patients who have received treatment for leukemia with chemotherapy as follows:
•Cohort 1:
•Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis)
•Patients who are candidates for a treatment with Nelarabine
•Cohort 2:
•Any chemotherapy or antibody therapy after the MRD assay leading to study inclusion (exception: intrathecal prophylaxis)
•Patients must have recovered from acute non-hematologic toxicity from previous therapies to ≤ grade I unless signs or symptoms are correlated to leukemia involvement
•Prior SCT ≤ 3 months from start of study treatment
+5 more criteria

Locations (14)

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

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

Key Dates

Start Date

October 22, 2024

Primary Completion Date

February 1, 2028

Completion Date

August 1, 2028

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

T-ALL

Interventions

Isatuximab

DRUG

Isatuximab

DRUG

Contacts

Nicola Goekbuget, MD

CONTACT

0049-6963016365 goekbuget@em.uni-frankfurt.de

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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