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

Memorial Sloan Kettering Cancer Center (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacokinetics

Study Design

Study Type:
Anticipated Enrollment :
20 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation
Actual Study Start Date :
Sep 9, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacokinetic directed melphalan

This is a feasibility study of pharmacokinetic (PK)-directed Captisol Enabled (CE) melphalan dosing to target an AUC of 8.5 (+/- 1.5) using a population PK model in lymphoma patients receiving BEAM [carmustine (BCNU) (B), etoposide (E), cytarabine (Ara-C) (A), and melphalan (M)], followed by autologous hematopoietic cell transplantation (AHCT). This study will enroll 20 patients with lymphoma planned for BEAM-AHCT. Carmustine IV will be given on day -6, followed by etoposide IV and cytarabine IV from day -5 to -2 as per the MSK inpatient or outpatient standard of care. The calculated melphalan dose based on population PK model to achieve the proposed melphalan target exposure [8.5 (+/- 1.5) mg*h/L], will be administered on day -1, and 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 to determine if the goal AUC was achieved.

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.

Outcome Measures

Primary Outcome Measures

  1. determine if this target AUC can be achieved [1 year]

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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center


  • Principal Investigator: Parastoo Dahi, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 22-086
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022