OncoMatch/Clinical Trials/NCT06648889
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Is NCT06648889 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Isatuximab and Isatuximab for t-all.
Treatment: Isatuximab · Isatuximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD38 overexpression (positive)
Patients with CD38 positive T-ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — induction I-II, consolidation I
after at least three chemotherapy cycles (induction I-II, consolidation I)
Cannot have received: antileukemic immunotherapy
Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment
Cannot have received: chemotherapy
Exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis
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)
Cannot have received: antibody therapy
Exception: intrathecal prophylaxis
Any chemotherapy or antibody therapy after the MRD assay leading to study inclusion (exception: intrathecal prophylaxis)
Cannot have received: Nelarabine (Nelarabine)
Patients who are candidates for a treatment with Nelarabine
Cannot have received: stem cell transplant
Prior SCT ≤ 3 months from start of study treatment
Cannot have received: investigational agent
Treatment with an investigational agent within 4 weeks from start of study treatment
Lab requirements
Blood counts
Cohort 1: Platelets ≥10,000/uL (platelet transfusion allowed), Hemoglobin ≥ 7.5 g/dl (red blood cell transfusion allowed); Cohort 2: Neutrophils ≥1,000/uL, Platelets ≥50,000/uL, Hemoglobin ≥9 g/dl
Kidney function
Serum creatinine ≤ 2 x ULN; Any serum creatinine level associated with a calculated creatinine clearance ≤ 40 mL/min
Liver function
Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator); AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator)
Regeneration from last chemotherapy defined as follows: Cohort 1: Platelets ≥10,000/uL (platelet transfusion allowed), Hemoglobin ≥ 7.5 g/dl (red blood cell transfusion allowed); Cohort 2: Neutrophils ≥1,000/uL, Platelets ≥50,000/uL, Hemoglobin ≥9 g/dl; Adequate liver function defined as follows: Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator); AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator); Adequate renal function defined as follows: Serum creatinine ≤ 2 x ULN; Any serum creatinine level associated with a calculated creatinine clearance ≤ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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