Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06764238
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acute Lymphoblastic Leukemia ALL
  • B Cell Acute Lymphoblastic Leukemia (B-ALL)
  • Childhood Leukemia, Acute Lymphoblastic

Eligibility Criteria

Sex
ALL
Age
1 Month - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab (Group A) — DRUG
    For Group A I/HR-ALL patients after induction remission phase, continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX) will be applied, subsequently followed by interim continuation, late intensification, and maintenance therapy
  • Venetoclax (nonRand Group) — DRUG
    For I/HR patients non eligible for blinatumomab randomization, venetoclax+ mini-hyperCVD will be applied after PVDL induction, subsequently followed by CAT as intensification, interim continuation, late intensification, and maintenance therapy
  • Blinatumomab (Group B) — DRUG
    For Group B I/HR-ALL patients after induction remission phase: a two 14-day cycles of blinatumomab, alternating with three cycles of HDMTX will be applied, subsequently followed interim continuation, late intensification, and maintenance therapy

Study Details

Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

Key Dates

Start date
Jan 3, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2029
Completion
Jun 30, 2031

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    After PVDL+CAT induction remission phase, patients randomized to Group A will be subjected to consolidation phase with continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX)
  • Experimental: Group B
    After PVDL+CAT induction remission phase, patients randomized to Group B will be subjected to consolidation phase with two 14-day cycles of blinatumomab, alternating with 3 cycles of high-dose methotrexate (HDMTX).
  • Experimental: NonRandonmized Group
    Patients who will not be subjected to blinatomomab randomization, will received PVDL + Venetoclax + mini-hyperCVD as induction phase , subsequently receiving CAT as early intensification.

Primary Outcome Measure

To investigate if Group B[2*(14-day blinatumomab + HDMTX*2)] can result in noninferior event-free survival (EFS) compared to Group A [28-day blinatumomab + HDMTX*4 [ Time Frame: Based on the above analysis in this study the investigators will randomize 1800 patients. The analysis will start1.5 years after the last patient is randomized. The expected study duration is approximately 6.5 years. ]

Central Contacts

Related Studies