Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06930105
Brief Summary:
This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.
Treatment Protocol
1. Low-intensity chemotherapy (VIP regimen)
* V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8.
* I (Idarubicin): 8 mg/m²/day on days 1 and 8.
* P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14.
2. Sequential induction therapy:
* Blinatumomab administered for 2 weeks following the VIP regimen.
3. Consolidation therapy for morphological complete remission (CR)
* Patients achieving CR receive two cycles of consolidation chemotherapy:
* Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).
* Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).
4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT):
* Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.
Patients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery \[CRi\]), MRD-negative rate (assessed by MFC/NGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute/chronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free/relapse-free survival (GRFS) post-transplant.
Study:
NCT06930105
Study Brief:
Protocol Section:
NCT06930105