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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoid Neoplasm
• Intervention / Treatment: Drug: Flu-Bu-Mel-E

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiong Hu; Phone Number: 601818 86-21-64370045; Email: hj10709@rjh.com.cn
• Study Contact Backup: Name: Jieling Jiang; Phone Number: 601818 86-21-64370045; Email: jjl12223@rjh.com.cn

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Blood & Marrow Transplantation Center, RuiJin Hospital
    • Contact: Jiong HU, M.D.; Phone Number: 601818 86-21-64370045; Email: hj10709@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment arm	Drug: Flu-Bu-Mel-E; Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	event defined as disease progression, relapse or death of any causes	1 year after allo-HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	event defined as death of any causes	1 year after allo-HSCT
Non relapse morality	event defined as death of any causes except for disease progression or relapse	1 year after allo-HSCT
Relapse	event defined as disease progression or relapse	1 year after allo-HSCT
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiong HU, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RJH-Lym-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No