Status:
NOT_YET_RECRUITING
Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL
Lead Sponsor:
Xianmin Song, MD
Conditions:
Acute Lymphoid Leukemia (ALL)
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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. Part...
Eligibility Criteria
Inclusion
- 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
- 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.
- Pulmonary: Severe respiratory insufficiency.
- Gastrointestinal: Active bleeding within 3 months.
- Uncontrolled concurrent illnesses that may compromise safety or study integrity.
- Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).
- Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.
- Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).
- Hypersensitivity to blinatumomab or its components.
- Inability to provide informed consent or comply with study procedures.
- Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06930105
Start Date
September 1 2025
End Date
May 1 2028
Last Update
August 6 2025
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