NCT05576532

Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia

The Efficacy and Safety of Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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;

Conditions

• T-lymphoblastic Lymphoma
• Relapsed Disease
• Refractory Lymphoma
• Refractory Leukemia
• Safety
• Efficacy, Self

Interventions

Type	Name	Description
DRUG	BCL2 Inhibitor plus IM2 regimen	oral bcl-2 inhibitor plus IM2(Ifosfamide plus Mitoxantrone or Idarubicin plus methotrexate) chemotherapy

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-10-10
• Completion: 2025-10-10
• First posted: 2022-10-12
• Last updated: 2023-06-28

Locations

1 site across 1 country: China