Clinical trial · no report yet · Phase 3
NCT03914625
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
- NCT03914625 ↗
- Active not recruiting
- National Cancer Institute (NCI)
- 11 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| Podcasts | 6 | |
| X threads | 3 | |
| YouTube | 2 |
The trial
ClinicalTrials.gov- Official title
- A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma; Down Syndrome
- Interventions
- Asparaginase Erwinia chrysanthemi; Blinatumomab; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Leucovorin Calcium; Mercaptopurine; Mercaptopurine Oral Suspension; Methotrexate; Pegaspargase; Prednisolone; Prednisone; Radiation Therapy; Radiation Therapy; Thioguanine; Vincristine Sulfate
- Arms
- Arm A (SR-Avg control) · Active comparator
- Arm B (SR-Avg experimental) · Experimental
- Arm C (SR-High Control) · Active comparator
- Arm D (SR-High experimental) · Experimental
- B-LLy · Experimental
- DS B-ALL · Experimental
- NCI SR or HR DS B-ALL · Experimental
- Enrollment
- 6,720 (estimated)
- Primary outcomes
- Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab
- DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)
- Sponsor
- National Cancer Institute (NCI)
- Start
- Jul 3, 2019
- Primary completion
- Sep 30, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT03914625 · updated Oct 1, 2026
Publications
linked from the registry- Gupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2025 Feb 27;392(9):875-891. doi: 10.1056/NEJMoa2411680. Epub 2024 Dec 7. PubMed 39651791
- Sora F, Annunziata M, Laurenti L, Giammarco S, Chiusolo P, Innocenti I, Autore F, Metafuni E, Galli E, Bacigalupo A, Ferrara F, Sica S. Blinatumomab as a successful and safe therapy in Down syndrome patients with relapsed/refractory b-precursor acute lymphoblastic leukaemia: Case reports and literature review. Pediatr Blood Cancer. 2021 Jul;68(7):e29044. doi: 10.1002/pbc.29044. Epub 2021 Apr 12. No abstract available. PubMed 33844429