NCT06930105Not yet recruitingPhase 2
Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Xianmin Song, MD
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT06930105
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 1 Sept 2025 to the primary completion date, 1 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled concurrent illnesses that may compromise safety or study integrity.
Other illness
- Non-de novo patients(i.e., relapsed/refractory disease).
- 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.
- Pulmonary: Severe respiratory insufficiency.
- Gastrointestinal: Active bleeding within 3 months.
- Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).
- Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).
- Hypersensitivity to blinatumomab or its components.
- Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.
Other
- BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
- Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.
- Inability to provide informed consent or comply with study procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.