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

Lymphoid Neoplasm Clinical Trial

Official title:

Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897139
• Other study ID #: RJH-Lym-2021
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong Hu
• Phone: 86-21-64370045
• Email: hj10709[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Lymphoid Neoplasm
• Neoplasms

Intervention

Drug:
• Flu-Bu-Mel-E
Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	event defined as disease progression, relapse or death of any causes	1 year after allo-HSCT
Secondary	Overall survival	event defined as death of any causes	1 year after allo-HSCT
Secondary	Non relapse morality	event defined as death of any causes except for disease progression or relapse	1 year after allo-HSCT
Secondary	Relapse	event defined as disease progression or relapse	1 year after allo-HSCT
Secondary	GVHD-free or relapse-free survival	event defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD	1 year after allo-HSCT