Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program (NCT06253637) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program
Italy31 participantsStarted 2024-10-17
Plain-language summary
The goal of this clinical trial is to test daratumumab in adult very high risk T-lineage lymphoblastic leukemia.
The main question it aims to answer is wether the addition of daratumumab daratumumab to the national standard of care is able to increase the rate of MRD-negative patients after induction therapy.
Participants will be treated with:
• daratumumab in combination with a pediatric-inspired treatment scheme - as in the previous GIMEMA LAL1913 protocol.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18-65 years.
✓. A diagnosis of T-ALL according to the 2022 International Consensus Classification (ICC) is required, either de novo or secondary to chemo-radiotherapy for another cancer. Pre-treatment with low-dose corticosteroids +/- cyclophosphamide in patients presenting with hyperleukocytosis is allowed.
✓. Availability of fresh bone marrow (BM) (or peripheral blood (PB) in patients with hyperleukocytosis) samples to perform diagnostic procedures. ).
✓. Bone marrow blast percentage at diagnosis ≥20%.
✓. CD38 positivity on ALL blasts (any level of positivity).
✓. ETP and near ETP at diagnosis according to internationally accepted criteria (appendix G) at diagnosis or other VHR T-ALL subtypes (WBC count \>100 x109/L; complex karyotype with ≥5 unrelated anomalies; other CD1a-negative immunophenotypes). T-Myeloid MPAL according to the 2022 ICC of Acute Leukemias of Ambiguous Lineage (appendix H) can also be eligible and considered as VHR.
✓. Availability of full cytological, cytochemical, immunophenotypic, cytogenetic and molecular disease characterization according to the EGIL and WHO classifications.
✓. An ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself, (and not by pre-existing comorbidities,) and is considered and/or documented to be reversible following the application of anti-leukemic therapy and appropriate supportive measures.
Exclusion criteria
✕. Diagnosis of B-lineage ALL, and Ph+ ALL.
What they're measuring
1
MRD-negativity rate after cycle 1
Timeframe: 1 month
Trial details
NCT IDNCT06253637
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
✕. Prior systemic chemotherapy for ALL (excluding cyclophosphamide during pre-phase).
✕. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum direct bilirubin \>3 mg/dL (unless attributable to Gilbert' syndrome or ALL) and/or ALT \>5x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
✕. Presence of serious, active, uncontrolled infections.
✕. A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with a life expectancy \<2 years.
✕. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.