Conditioning regimen for patients with lymphoid malignancies undergoing stem cell transplant
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
This study tests a new combination of medications to see if it helps patients with lymphoid cancers get ready for a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | fludarabine |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04897139 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and feasibility of a conditioning regimen that includes fludarabine, busulfan, melphalan, and etoposide for patients with lymphoid malignancies. The study aims to determine how well this combination prepares patients for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants must have a suitable donor and meet specific health criteria, ensuring they can tolerate the treatment. The trial focuses on improving outcomes for patients facing these challenging conditions.
Who should consider this trial
Good fit: Ideal candidates are patients with lymphoid malignancies who have an HLA-matched donor and an ECOG performance status of less than 3.
Not a fit: Patients with poor liver, renal, or cardiac function, or those with an ECOG performance status of 3 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this regimen could enhance the effectiveness of stem cell transplants for patients with lymphoid malignancies.
How similar studies have performed: Other studies have shown promising results with similar conditioning regimens, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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%)
Where this trial is running
Shanghai
- Blood & Marrow Transplantation Center, RuiJin Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jiong HU — Ruijin Hospital
- Study coordinator: Jiong Hu
- Email: hj10709@rjh.com.cn
- Phone: 86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.