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Alkylating agents
Melphalan for Lymphoma
Phase 1
Recruiting
Led By Parastoo Dahi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a newer, more personalized way of calculating melphalan dose is more effective and has fewer side effects than the standard dose.
Who is the study for?
This trial is for adults aged 18-79 with lymphoma (including T-cell, B-cell, Hodgkin's, Non-Hodgkin's) who are responding to chemotherapy and scheduled for a stem cell transplant. They must have good heart function, kidney function, lung capacity, and a sufficient dose of stem cells available. Pregnant women or those with disease progression since last therapy cannot participate.
What is being tested?
The study tests if calculating the melphalan chemotherapy dose using a population PK model before autologous hematopoietic cell transplant (AHCT) is practical. This method aims to tailor doses individually based on previous patient data rather than using standard fixed doses.
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of melphalan may include nausea, vomiting, diarrhea, mouth sores, decreased blood counts leading to increased infection risk or bleeding tendencies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
determine if this target AUC can be achieved
Side effects data
From 2015 Phase 1 & 2 trial • 35 Patients • NCT0098958660%
Infusion Reactions
54%
Lymphopenia
23%
Leukopenia
20%
Thrombocytopenia
14%
Neutropenia
14%
Anemia
14%
Infection
11%
Hyperglycemia
9%
Fatigue
9%
Infusion Reaction
6%
Hypophosphatemia
6%
Chills
6%
Nausea
6%
Diarrhea
6%
Pulmonary embolus
6%
Death
3%
Pneumonia
3%
Bacteremia
3%
Supraventricular tachycardia
3%
Hyperbilirubinemia
3%
Fever without neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients From Phase I and Phase II
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Pharmacokinetic directed melphalanExperimental Treatment1 Intervention
In cohort 2, carmustine will be on Day -7, cytrabine and etoposide on Day -6 to Day -3, and melphalan (70mg/m2 /day IV) will be administered on day -2 followed by PK samples to determine the melphalan dose on day -1 using the population PK model. PK samples will be collected again after the dose on day -1 to confirm the total melphalan AUC of 8.5 (+/- 1.5) mg\*h/L. 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.
Group II: Cohort 1: Pharmacokinetic directed melphalanExperimental Treatment1 Intervention
This is a feasibility study of pharmacokinetic (PK)-directed Captisol Enabled (CE) melphalan dosing to target an AUC of 8.5 (+/- 1.5) using a population PK model in lymphoma patients receiving BEAM \[carmustine (BCNU) (B), etoposide (E), cytarabine (Ara-C) (A), and melphalan (M)\], followed by autologous hematopoietic cell transplantation (AHCT). This study will enroll patients with lymphoma planned for BEAM-AHCT. Carmustine IV will be given on day -6, followed by etoposide IV and cytarabine IV from day -5 to -2 as per the MSK inpatient or outpatient standard of care. The calculated melphalan dose based on population PK model to achieve the proposed melphalan target exposure \[8.5 (+/- 1.5) mg\*h/L\], will be administered on day -1, and 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 to determine if the goal AUC was achieved.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,038 Total Patients Enrolled
157 Trials studying Lymphoma
9,279 Patients Enrolled for Lymphoma
Parastoo Dahi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Lymphoma
28 Patients Enrolled for Lymphoma