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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method to calculate the dose of a chemotherapy drug called melphalan for patients with lymphoma who are preparing for a specific type of treatment known as an autologous hematopoietic cell transplant (AHCT). Currently, the standard melphalan dose is based on a person's height and weight, but this study is testing a more personalized approach that uses previous patient data to determine the best dose for each individual. Researchers hope that this tailored dosing method will still be effective while causing fewer side effects than the standard treatment.

To participate in this trial, you need to be between 18 and 79 years old and have been diagnosed with any type of lymphoma, including Hodgkin or non-Hodgkin lymphoma. You should also have a good performance status and meet certain health criteria, such as heart and lung function. If you join the study, you can expect to receive the personalized dose of melphalan as part of the BEAM chemotherapy regimen before your transplant. It’s important to know that this trial is still in the early stages, and participants will be closely monitored throughout the process.

Gender

ALL

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