NCT05466318

ChiCGB vs BEAM in High-risk or R/R Lymphomas

ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, T-Cell

Interventions

Type	Name	Description
DRUG	Chidamide	30 mg oral twice weekly for 2 weeks
DRUG	Cladribine	6 mg/m2 intravenously once daily @ Day -7 \~ -3
DRUG	Gemcitabine	2500 mg/m2 intravenously @ Day -7, -3
DRUG	Busulfan	3.2 mg/kg intravenously once daily @ Day -7 \~ -4
DRUG	Carmustine	300 mg/m2 intravenously @ Day -8
DRUG	Etoposide	200 mg/m2 intravenously once daily @ Day -7 \~ -4
DRUG	Cytarabine	400 mg/m2 intravenously once daily @ Day -7 \~ -4
DRUG	Melphalan	140 mg/m2 intravenously @ Day -3
PROCEDURE	Autologous hematopoietic stem cell transplant	autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-07-20
• Last updated: 2022-07-25

Locations

11 sites across 1 country: China