Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06930105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL
Sponsor:
Xianmin Song, MD
Organization:
Study Overview
Official Title:
Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: