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

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 2

Conditions: Lymphoid Neoplasm

Treatments: Drug: Flu-Bu-Mel-E

Study type: Interventional

Funder types: Other

Identifiers

NCT04897139

RJH-Lym-2021

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

treatment arm

Experimental group

Description:

treatment arm

Treatment:

Drug: Flu-Bu-Mel-E