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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04897139
Enrollment
23
Registered
2021-05-21
Start date
2021-01-01
Completion date
2024-12-01
Last updated
2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoid Neoplasm

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.

Interventions

DRUGFlu-Bu-Mel-E

Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

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%)

Design outcomes

Primary

MeasureTime frameDescription
disease-free survival1 year after allo-HSCTevent defined as disease progression, relapse or death of any causes

Secondary

MeasureTime frameDescription
Overall survival1 year after allo-HSCTevent defined as death of any causes
Non relapse morality1 year after allo-HSCTevent defined as death of any causes except for disease progression or relapse
Relapse1 year after allo-HSCTevent defined as disease progression or relapse
GVHD-free or relapse-free survival1 year after allo-HSCTevent defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD

Countries

China

Contacts

Primary ContactJiong Hu
hj10709@rjh.com.cn86-21-64370045
Backup ContactJieling Jiang
jjl12223@rjh.com.cn86-21-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026