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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Washington University School of Medicine
St Louis, Missouri, United States
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
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: Day -7 through Day 30
Treatment-related Mortality (TRM)
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
Time frame: 100 days
Efficacy as Measured by Response Rates
* The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion. * Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
Time frame: Up to Day 100
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 1 year.
Time frame: 1 year
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 2 years.
Time frame: 2 years
Time to Engraftment (Neutrophil)
Time from the date of the transplant to the date of neutrophil engraftment.
Time frame: Assessed up to day 30
Time to Engraftment (Platelet)
Time from the date of transplant to the date of platelet engraftment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Assessed up to day 100