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 (Sep 2026). This Phase 2 trial studies Isatuximab for t-all.
Treatment: 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
Treatments studied
Immunotherapy
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD38 expression (positive)
CD38 positive T-ALL/T-LBL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
after at least three chemotherapy cycles (induction I-II, consolidation I)
Lab requirements
Blood counts
Platelets ≥10,000/uL (platelet transfusion allowed); Hemoglobin ≥ 7.5 g/dl (red blood cell transfusion allowed)
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: Platelets ≥10.000/uL (platelet transfusion allowed); Hemoglobin ≥ 7.5 g/dl (red blood cell transfusion allowed); 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.
Frequently asked questions
Is NCT06648889 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy.
Does this trial require CD38?
Yes, CD38 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages