Clinical trial · Interventional
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 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)
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL, Adult | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Philadelphia-Negative ALL | B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab Injection [Blincyto] | Drug | Blinatumomab | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced-dose Chemotherapy Followed by Blinatumomab
- description
- Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2\[max 2mg\], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued.
- interventionNames
- Drug: Blinatumomab Injection [Blincyto]
- type
- ACTIVE_COMPARATOR
- label
- hyperCVAD
- description
- CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14
- interventionNames
- Drug: Doxorubicin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 15-65 * Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria * Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days * ECOG score 0-3 * Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration) * Renal function: endogenous creatinine clearance ≧30ml/min * Patients must be able to understand and willing to participate in the study and must sign the informed consent form. Exclusion Criteria: * Ph+ (BCR-ABL1 positive) ALL * T cells ALL * Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease * Acute mixed-cell leukemia * Central nervous system leukemia * HIV infection * HBV-DNA or HCV-RNA positive * Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator * Pregnant or breastfeeding patients * The study patient was refused enrollment
References
Publications (0)
Data not yet available