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Trial Title:
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
NCT ID:
NCT05540340
Condition:
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, T-Cell
Hodgkin Disease
Conditions: Keywords:
Pharmacokinetics
Carmustine
Etoposide
Melphalan
Cytarabine
22-086
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Pharmacokinetics
Description:
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.
Arm group label:
Cohort 1: Pharmacokinetic directed melphalan
Intervention type:
Other
Intervention name:
Pharmacokinetics
Description:
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.
Arm group label:
Cohort 2: Pharmacokinetic directed melphalan
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Parastoo Dahi, MD
Phone:
646-608-3733
Contact backup:
Last name:
Gunjan Shah, MD
Phone:
646-608-3734
Start date:
September 9, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05540340
http://www.mskcc.org/mskcc/html/44.cfm
