Clinical trial · Observational
Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study
Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Acute, Adult | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Reduced-dose chemotherapy followed by blinatumomab induction treatment group
- description
- Patients aged 15-65 with newly diagnosed Ph-negative B-ALL undergoing frontline induction therapy with reduced-dose chemotherapy followed by blinatumomab.
- interventionNames
- Drug: Blinatumomab
Primary outcomes (2)
- measure
- The overall response rate
- timeFrame
- At the end of induction treatment from day 28 to day 35
- description
- The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
- measure
- Minimal Residual Disease (MRD) negativity rate after induction therapy
- timeFrame
- At the end of induction treatment from day 28 to day 35
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 15-65 years, both male and female are eligible; * Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing \>20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative; * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2; * Organ function tests must meet all the following criteria: Total bilirubin \<1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \<2.5×ULN (if liver is involved, then ALT and AST \<5×ULN are allowed); Creatinine \<1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits. * Cardiac color Doppler echocardiography ejection fraction ≥45%; * Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment). Exclusion Criteria: * Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment; * Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis; * Patients participating in other clinical studies simultaneously; * Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study; * A history of definite neurological or psychiatric disorders, including epilepsy or dementia; * Major surgery within the last 4 weeks or not recovered from previous surgery; * Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention; * Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women; * Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.); * Confirmed positive status for human immunodeficiency; * Active severe infections that cannot be controlled by oral or intravenous antibiotics; * Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and/or excipients); * Existence of bleeding disorders unrelated to ALL.
References
Publications (1)
- DERIVEDDavis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463