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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06648889 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antileukemic immunotherapy, chemotherapy, antibody therapy disqualifies patients from enrollment.
Does this trial require CD38?
Yes, CD38 overexpression 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