Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT01969435
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
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: BCNU, BiCNU®
Other names: VP-16, Vepesid
Other names: Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside, Ara-C
Time frame: Day -7 through Day 30
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Time frame: 100 days
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
Time frame: Up to Day 100
Time frame: 1 year
Percentage of patients who survive without any signs or symptoms of cancer at 1 year.
Time frame: 2 years
Percentage of patients who survive without any signs or symptoms of cancer at 2 years.
Time frame: Assessed up to day 30
Time from the date of the transplant to the date of neutrophil engraftment.
Time frame: Assessed up to day 100
Time from the date of transplant to the date of platelet engraftment.
Washington University School of Medicine
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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