drugset / Trial / NCT05576532
Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
Phase 2
Unknown
30 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of Venetoclax plus IM2 regimen for relapsed and refractory T lymphoblastic lymphoma/leukemia. Dosage of Venetoclax:100mg/d-400mg/d(dose adjustment when concomitant used with CYP3A inhibitor) for 1-28 days (at least 7 days); IM2 regimen: Ifosfamide 1-1.5g/m2/d for 5 days; Mitoxantrone 6-8g/m2/d for 3 days( or Liposome mitoxantrone 20mg/m2 d1 or Idarubicin 6-8mg/m2/d for 3 days) ;methotrexate 1-1.5g/m2/d for 1 day;
Timeline
- Start
- 2023-01-10
- Primary completion
- 2024-10-10
- Completion
- 2025-10-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 100 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Idarubicin | Small molecule | 6 mg | — |
| Background | Idarubicin | Small molecule | 8 mg | — |
| Background | Ifosfamide | Small molecule | 1 g | — |
| Background | Ifosfamide | Small molecule | 1.5 g | — |
| Background | Methotrexate | Small molecule | 1 g | — |
| Background | Methotrexate | Small molecule | 1.5 g | — |
| Background | Mitoxantrone | Small molecule | 20 mg | — |
| Background | Mitoxantrone | Small molecule | 6 g | — |
| Background | Mitoxantrone | Small molecule | 8 g | — |