NCT05540340Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 12 Sept 2022
- Start date
- 9 Sept 2022
- Primary completion date
- Sept 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- NCT number
- NCT05540340
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 9 Sept 2022 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disease progression by IWG Working Group since last therapy
- 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
Lab values
- 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
Other
- Pregnant or lactating females
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.