Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT

Phase 2

Recruiting

• Conditions: Lymphoid Neoplasm
• Interventions: Drug: Flu-Bu-Mel-E

• Registration Number: NCT04897139
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-21
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• lymphoid malignancies
• donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
• patients with ECOG <3

Exclusion Criteria

• inform consent not provided
• ECOG >=3
• poor liver function (enzyme >2N or bilirubin >2N)
• poor renal function (Scr >2N)
• poor cardiac function (EF <45%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Flu-Bu-Mel-E	treatment arm

Primary Outcome Measures

Name	Time	Method
disease-free survival	1 year after allo-HSCT	event defined as disease progression, relapse or death of any causes

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year after allo-HSCT	event defined as death of any causes
Non relapse morality	1 year after allo-HSCT	event defined as death of any causes except for disease progression or relapse
GVHD-free or relapse-free survival	1 year after allo-HSCT	event defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD
Relapse	1 year after allo-HSCT	event defined as disease progression or relapse

Trial Locations

Locations (1)

Blood & Marrow Transplantation Center, RuiJin Hospital; 🇨🇳 Shanghai, China