drugset / Trial / NCT03384654
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Timeline
- Start
- 2018-05-14
- Primary completion
- 2022-09-22
- Completion
- 2022-09-27
Publications
- Bhatla T, Hogan LE, Teachey DT, Bautista F, Moppett J, Velasco Puyo P, Micalizzi C, Rossig C, Shukla N, Gilad G, Locatelli F, Baruchel A, Zwaan CM, Bezler NS, Rubio-San-Simon A, Taussig DC, Raetz EA, Mao ZJ, Wood BL, Alvarez Arias D, Krevvata M, Nnane I, Bandyopadhyay N, Lopez Solano L, Dennis RM, Carson R, Vora A. Daratumumab in pediatric relapsed/refractory acute lymphoblastic leukemia or lymphoblastic lymphoma: the DELPHINUS study. Blood. 2024 Nov 21;144(21):2237-2247. doi: 10.1182/blood.2024024493.
- Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1 g | — |
| Background | Cytarabine | Small molecule | 75 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | 60 mg/m2 | Oral |
| Background | Methotrexate | Small molecule | 5 g | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | — |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | — |