Actively Recruiting
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Led by Goethe University · Updated on 2026-01-15
40
Participants Needed
14
Research Sites
197 weeks
Total Duration
On this page
Sponsors
G
Goethe University
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with CD38 positive T-ALL fitting cohort 1 or cohort 2 definitions
- Cohort 1: Relapse or primary refractory disease with 3% blasts in bone marrow after at least three chemotherapy cycles
- Cohort 1: Early relapse within 12 months from first CR, late relapse after 12 months, primary refractory disease without CR, relapse after stem cell transplantation, refractory relapse with no response to salvage therapy, or second/later relapse
- Availability of patient material for central MRD assessment or predefined marker
- Cohort 2: Complete hematological remission with less than 5% blasts in bone marrow and no extramedullary disease after at least three chemotherapy cycles
- MRD level 310-4 detected by central reference lab with at least one marker of minimum sensitivity 10-4
- MRD detection after at least 2 weeks from last systemic chemotherapy
- ECOG status 0-2 for cohort 1, 0-1 for cohort 2
- Age 18 years or older
- Signed informed consent
- Willingness and ability to comply with study visits, treatments, and tests
- Adequate blood counts: cohort 1 platelets 310,000/uL, hemoglobin 37.5 g/dl; cohort 2 neutrophils 31,000/uL, platelets 350,000/uL, hemoglobin 39 g/dl
- Adequate liver function: bilirubin 31.5 ULN, AST and ALT 32.5 x ULN unless due to liver infiltration
- Adequate renal function: serum creatinine 32 x ULN, creatinine clearance 340 mL/min
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use 2 reliable birth control methods or abstain from heterosexual intercourse
- Men with sexually active female partners must use barrier contraception
- Participation in German Multicenter Study Group for Adult ALL registry
You will not qualify if you...
- Extramedullary involvement except non-bulky lymph nodes (<7.5 cm), splenomegaly, or hepatomegaly
- Prior antileukemic immunotherapy within 2 weeks before Isatuximab
- Cohort 1: Chemotherapy within 2 weeks before Isatuximab except short pre-phase therapy
- Cohort 1: Candidates for Nelarabine treatment
- Cohort 2: Chemotherapy or antibody therapy after MRD assay except intrathecal prophylaxis
- Unrecovered acute non-hematologic toxicity > grade I unless due to leukemia
- Stem cell transplant within 3 months before study treatment
- Acute graft-versus-host disease (GvHD) grade II or higher or active chronic GvHD requiring systemic treatment
- Systemic GvHD prophylaxis or treatment within 2 weeks before study
- Known HIV, hepatitis B surface antigen positivity, or hepatitis C history
- Unstable or severe uncontrolled medical conditions
- Investigational agent treatment within 4 weeks before study
- Active malignancies except certain treated cancers or malignancies disease-free for 2 or more years
- Current serious active infections or recent deep tissue infections within 4 months
- Known allergies or intolerance to boron, Mannitol, corticosteroids, monoclonal antibodies including Isatuximab, or mammalian-derived products
- Active infection or other concurrent diseases interfering with study
- Pregnant or breastfeeding females
- Live vaccine within 4 weeks before study
- Other severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University Hospital Augsburg, II. Medizinischen Klinik, Hämatologie, internistische Onkologie und Hämostaseologie
Augsburg, Germany, 86156
Actively Recruiting
2
Charité Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumorimmunologyt Hämatologie
Berlin, Germany, 12203
Actively Recruiting
3
Klinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Actively Recruiting
4
University Hospital Düsseldorf, Department of Hematology, Oncology and Clinical Immunology
Düsseldorf, Germany, 40225
Actively Recruiting
5
University Hospital Erlangen AöR, Department of Medicine 5
Erlangen, Germany, 91054
Actively Recruiting
6
Goethe University Hospital Frankfurt, Department of Medicine, Hematology and Oncology
Frankfurt am Main, Germany, 60580
Actively Recruiting
7
University Hospital Hamburg-Eppendorf, Department of Medicine II
Hamburg, Germany, 20251
Actively Recruiting
8
University Hospital Heidelberg, Department V, Hematology, Oncology and Rheumatology
Heidelberg, Germany, 69120
Actively Recruiting
9
University Hospital Schleswig-Holstein, Campus Kiel, Medical Department II
Kiel, Germany, 24105
Actively Recruiting
10
University Hospital Leipzig; Klinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Bereich Hämatologie und Zelltherapie
Leipzig, Germany, 04103
Actively Recruiting
11
University Hospital München-Großhadern, Medizinische Klinik und Poliklinik III
München, Germany, 81377
Actively Recruiting
12
University Hospital Münster, Medizinische Klinik A / KMT-Zentrum
Münster, Germany, 48149
Actively Recruiting
13
Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Onkologie und Hämatologie
Oldenburg, Germany, 26135
Actively Recruiting
14
Robert-Bosch-Krankenhaus; Abteilung für Hämatologie, Onkologie und Palliativmedizin
Stuttgart, Germany, 70376
Actively Recruiting
Research Team
N
Nicola Goekbuget, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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