Using a personalized melphalan dose for lymphoma patients undergoing transplant
Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation
This study is testing a new way to figure out the right dose of melphalan for lymphoma patients getting a stem cell transplant to see if a personalized dose can work better and cause fewer side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05540340 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a new method for calculating the melphalan dose for lymphoma patients receiving an autologous hematopoietic cell transplant (AHCT). Instead of using a standard fixed dose based on height and weight, the study will employ a population pharmacokinetic model to determine a tailored dose for each individual. Researchers believe this personalized approach may maintain effectiveness while reducing side effects compared to traditional dosing methods. Participants will be monitored for their response to this optimized treatment during the study.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 79 diagnosed with any type of lymphoma who are scheduled for BEAM-AHCT.
Not a fit: Patients with disease progression since their last therapy or those with contraindications to melphalan will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer chemotherapy dosing for lymphoma patients undergoing transplant.
How similar studies have performed: Other studies have shown promise in using personalized dosing strategies, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Parastoo Dahi, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Parastoo Dahi, MD
- Email: dahip@mskcc.org
- Phone: 646-608-3733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.