Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Recruiting
Phase 2
Interventional Study
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 15 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 101 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Other
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About This Trial
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strate…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥15 years and ≤65 years.
2. Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%
3. De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use…
Contacts