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NCT05540340 | RECRUITING | Lymphoma

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

Memorial Sloan Kettering Cancer Center

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

Lymphoma

Lymphoma, B-Cell

Lymphoma, T-Cell

Lymphoma, Hodgkin

Lymphoma, Non-Hodgkin

Intervention/treatment

Pharmacokinetics

Pharmacokinetics

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation
Actual Study Start Date : 2022-09-09
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant

Location Details

NCT05540340

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065