Lymphoma, Lymphoma, B-Cell, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
Conditions
Keywords
Pharmacokinetics, Carmustine, Etoposide, Melphalan, Cytarabine, 22-086
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.
Interventions
OTHERPharmacokinetics
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORParastoo Dahi, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed