RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

Quick Facts

Study Start:2022-09-09
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05540340

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age18 - 79 years old
  2. * Diagnosed with any type of lymphoma \[Hodgkin, non-Hodgkin (B- or T-cell)\] and planned for BEAM-AHCT
  3. * KPS \> 70
  4. * Cardiac ejection fraction of \> 45%
  5. * Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
  6. * Creatinine clearance of ≥ 40 mL/min
  7. * Completion of most recent systemic therapy within 12 weeks of enrollment
  8. * Complete or partial response to systemic chemotherapy by IWG Working Group Criteria.
  9. * 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.
  10. * Minimum stem cell dose of 2 x 10\*6 CD34+ cells/kg
  1. * Disease progression by IWG Working Group since last therapy
  2. * Pregnant or lactating females
  3. * Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
  4. * Any known allergy or allergic reactions to Captisol
  5. * 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

Study Contact

Parastoo Dahi, MD
CONTACT
646-608-3733
dahip@mskcc.org
Gunjan Shah, MD
CONTACT
646-608-3734

Principal Investigator

Parastoo Dahi, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Parastoo Dahi, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2022-09-09
Study Completion Date2025-09

Study Record Updates

Study Start Date2022-09-09
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Pharmacokinetics
  • Carmustine
  • Etoposide
  • Melphalan
  • Cytarabine
  • 22-086

Additional Relevant MeSH Terms

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