NCT01969435

Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT

Conditions

• Hodgkin Disease
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Carmustine
DRUG	Etoposide phosphate
DRUG	Cytarabine
DRUG	Melphalan HCl (propylene glycol-free)

Timeline

• Start date: 2014-03-19
• Primary completion: 2015-09-30
• Completion: 2017-05-31
• First posted: 2013-10-25
• Last updated: 2018-02-13
• Results posted: 2016-11-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study