Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL

NCT06930105 | Not Yet Recruiting Phase 2

• 1 other identifier: SHSYXY-Blina-Ph-B ALL-2025
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

• 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.
• Sequential induction therapy:
• Blinatumomab administered for 2 weeks following the VIP regimen.
• 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).
• 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.

Conditions

Acute Lymphoid Leukemia (ALL)

Outcome Measures

Primary Outcomes (1)

• RFS

  18-month relapse-free survival (RFS) rate post-allo-HSCT in newly diagnosed Ph- B-ALL patients treated with low-intensity chemotherapy followed by short-course blinatumomab induction.

  three year

Study Arms (1)

Blina combined low-intensity therapy

EXPERIMENTAL

Drug: Blinatumomab plus Reduced-dose Chemotherapy

Interventions

Blinatumomab plus Reduced-dose Chemotherapy DRUG

Newly diagnosed Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (Ph-negative B-ALL) patients aged 18-60 years were enrolled. 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 res

Blina combined low-intensity therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score \<3.
• \. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:
• Bone marrow morphology
• Cytochemistry
• Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)
• Chromosomal analysis
• Molecular/genetic testing. 3. Planned allo-HSCT candidates must have an eligible hematopoietic stem cell donor, including:
• HLA-matched sibling donors
• Unrelated donors (9/10 or 10/10 HLA allele-matched by high-resolution typing)
• Haploidentical related donors. 4. No significant organ dysfunction:
• Liver: ALT/AST ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN.
• Kidney: BUN and serum creatinine ≤1.25× ULN.
• Cardiac:
• No acute myocardial infarction or severe arrhythmia on ECG.
• Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; no significant cardiomegaly, valvular disease, or congenital heart defects.

You may not qualify if:

• Non-de novo patients(i.e., relapsed/refractory disease).
• BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
• Uncontrolled active infections or viral diseases:
• Active bacterial, viral, or fungal infections requiring treatment.
• Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.
• Hepatitis C: HCV antibody-positive with detectable HCV RNA.
• Syphilis: Positive TRUST test.
• HIV: HIV antibody-positive.
• Major organ dysfunction or comorbidities:
• Cardiovascular:
• Uncontrolled hypertension, hypertensive crisis, or encephalopathy.
• History of congestive heart failure (CHF), unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia).
• Arterial thrombosis within 3 months (e.g., stroke, transient ischemic attack).
• Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months.
• Coronary angioplasty, defibrillation, or other high-risk cardiovascular procedures.

Sponsors & Collaborators

• Xianmin Song, MD: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xianmin song

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

xia shao

CONTACT

15216632623; maizidemaidi@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share