NCT05540340

A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population PK model) in BEAM chemotherapy before AHCT. Standard dose is fixed for everybody and is calculated using height and weight. The population PK model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. Study researchers think that the dose calculated using the population PK model may still be effective but have less side effects than the standard melphalan dose.

Conditions

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, T-Cell
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
OTHER	Pharmacokinetics	Six peripheral blood samples of 5 ml in lithium heparin tubes will be collected at 5, 15, 30, 40, 75, and 150 minutes after the melphalan, for PK testing. The first four time points are +/- 2 min and the last two time points are +/- 5 minutes.
OTHER	Pharmacokinetics	Six peripheral blood samples of 5 ml in lithium heparin tubes will be collected at 5, 15, 30, 40, 75, and 150 minutes after the melphalan to determine the actual AUC achieved using the population PK.

Timeline

• Start date: 2022-09-09
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2022-09-14
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States