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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age18 - 79 years old
Diagnosed with any type of lymphoma [Hodgkin, non-Hodgkin (B- or T-cell)] and planned for BEAM-AHCT
KPS > 70
Cardiac ejection fraction of > 45%
Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
Creatinine clearance of ≥ 40 mL/min
Completion of most recent systemic therapy within 12 weeks of enrollment
Complete or partial response to systemic chemotherapy by IWG Working Group Criteria.
Total bilirubin < 2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST & ALT < 2.5 ULN.
Minimum stem cell dose of 2 x 10*6 CD34+ cells/kg

Exclusion criteria

Disease progression by IWG Working Group since last therapy
Pregnant or lactating females
Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
Any known allergy or allergic reactions to Captisol
Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

Treatment and study plan

Pharmacokinetics

Other

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.

Primary outcomes

determine if this target AUC can be achieved

Time frame: 1 year

within a range of 8.5 (+/- 1.5) mg*h/L using population PK model.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Sep 14, 2022
Registry last updated: Mar 6, 2026

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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