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

March 4, 2026 updated by: Memorial Sloan Kettering Cancer Center

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: 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 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.
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.
Experimental: Cohort 2: Pharmacokinetic directed melphalan
In cohort 2, carmustine will be on Day -7, cytrabine and etoposide on Day -6 to Day -3, and melphalan (70mg/m2 /day IV) will be administered on day -2 followed by PK samples to determine the melphalan dose on day -1 using the population PK model. PK samples will be collected again after the dose on day -1 to confirm the total melphalan AUC of 8.5 (+/- 1.5) mg*h/L. 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, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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