Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
RJH-Lym-2021
Description
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.
Trial arms
Trial start
2021-01-01
Estimated PCD
2024-06-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Flu-Bu-Mel-E
Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2
Arms:
treatment arm
Size
23
Primary endpoint
disease-free survival
1 year after allo-HSCT
Eligibility criteria
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%)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ESTIMATED'}}
Updated at
2023-10-25

1 organization

1 product

1 indication

Organization
Shanghai Jiao Tong University School of Medicine
Product
Flu-Bu-Mel-E
Indication
Lymphoid Neoplasm