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

August 5, 2025 updated by: Xianmin Song, MD

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score <3.

2. 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.
  • Pulmonary: FEV1, FVC, and DLCO ≥60% of predicted values. 5. Contraception:

  • Men, women of childbearing potential (postmenopausal women must be amenorrheic for ≥12 months), and their partners must use investigator-approved effective contraception during treatment and for ≥12 months after the last study intervention.

    6. Informed consent: Patients and their legal guardians must provide written informed consent, demonstrate willingness to undergo allo-HSCT, and agree to comply with treatment protocols, follow-up schedules, and laboratory tests.

Exclusion Criteria:

  1. Non-de novo patients(i.e., relapsed/refractory disease).
  2. BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).

  3. 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.

  4. 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.
    • Pulmonary: Severe respiratory insufficiency.
    • Gastrointestinal: Active bleeding within 3 months.
  5. Uncontrolled concurrent illnesses that may compromise safety or study integrity.
  6. Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).
  7. Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.
  8. Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).
  9. Hypersensitivity to blinatumomab or its components.
  10. Inability to provide informed consent or comply with study procedures.
  11. Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blina combined low-intensity therapy
Drug: Blinatumomab plus Reduced-dose Chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS
Time Frame: three year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xianmin Song, MD

Investigators

  • Study Chair: Xianmin song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSYXY-Blina-Ph-B ALL-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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