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Newly-diagnosed Pediatric T-cell ALL Protocol

Study acronym: CCCG-TALL-2025
StatusRecruiting
PhasePhase 2/3
Started2025-03-11
View on ClinicalTrials.gov ↗

Amendment history

2025-08-23
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03→confirmed 2025-03-11
Study sites26→27
2025-03-11
Study Status, Oversight, Outcome Measures, Contacts/Locations v1
Start date2025-02-22→2025-03
Secondary endpoints4 entries, revised
ToIncidence assessof gradeGrade 4 toxicities,Treatment-Emergent tolerabilityAdverse andEvents safety(TEAE) associated with venetoclax and homoharringtonine
Primary endpoints4 entries, revised
To evaluate the endEnd of induction (EOI) measurable residual diseases (MRD)-negat [...] induction on CCCG-ALL-2020 in treating ETP/near-ETP T-ALL. To evaluate the endEnd-of-induction(EOI) measurable residual diseases (MRD)-negati [...]
Study sitesdetails revised at 1 of 26 sites
2025-02-25
Original filing
This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).
Trial Details
NCT Number NCT06855810
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acute Lymphoblastic Leukemia, Childhood Leukemia, Acute Lymphoblastic, T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Enrollment 610 participants
Start Date 2025-03-11
Primary Completion 2030-06 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-26