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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 • NCT00989586

60%

Infusion Reactions

54%

Lymphopenia

23%

Leukopenia

20%

Thrombocytopenia

14%

Neutropenia

14%

Anemia

14%

Infection

11%

Hyperglycemia

Fatigue

Infusion Reaction

Hypophosphatemia

Chills

Nausea

Diarrhea

Pulmonary embolus

Death

Pneumonia

Bacteremia

Supraventricular tachycardia

Hyperbilirubinemia

Fever without neutropenia

100%

80%

60%

40%

20%

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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