NCT06742463

VHAG in Treating R/R T-ALL/LBL

Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recurrence of ALL patients. In addition, most relapsed T-ALL/LBL patients relapse during first-line treatment. Once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.

Detailed description

This is a prospective, single-arm, phase II and open-label study. A total of 50 R/R T-ALL/LBL participants will be enrolled. The primary endpoint is complete remission with or without peripheral blood cell recovery. The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF. The purpose of this study is to explore efficacy of the VHAG in the treatment of R/R T-ALL/LBL patients.

Conditions

• Acute T Lymphpblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	Venetoclax	BCL-2 inhibitor
DRUG	homoharringtonine	alkaloid
DRUG	Cytarabine (Ara-C)	Metabolic antagonist.
DRUG	G-CSF	Granulocyte colony-stimulating factor

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-06-30
• Completion: 2028-06-30
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China