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

Lymphoma Clinical Trial

Official title:

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540340
• Other study ID #: 22-086
• Status: Recruiting
• Phase: Phase 1
• Start date: September 9, 2022
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Parastoo Dahi, MD
• Phone: 646-608-3733
• Email: dahip[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine if this target AUC can be achieved	within a range of 8.5 (+/- 1.5) mg*h/L using population PK model.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center