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Alkylating agents

Pharmacokinetics for Lymphoma

N/A
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: 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 20 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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,869 Total Patients Enrolled
155 Trials studying Lymphoma
8,719 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical trial?

"The trial requires twenty participants diagnosed with any form of lymphoma, aged 18 to 79. To meet the enrolment criteria for this study applicants must have a Karnofsky Performance Status of over 70%, haemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) no lower than 45%, creatinine clearance rate higher than 40 mL/min, total bilirubin levels underneath 2.0 mg/dL in absence Gilbert's disease or 3.0 mg/dL if suspected; AST and ALT both below 2.5 ULN; stem cell dose of at least two times 10*6 CD34+"

Answered by AI

Are recruitment efforts underway for this research investigation?

"Clinicaltrials.gov data suggests that recruitment for this trial, which was initially publicized on September 9th 2022, is ongoing as of the most recent update from September 12th 2022."

Answered by AI

Are there any age restrictions on participants for this investigation?

"Individuals 18-70 can apply for this medical trial, though there are 322 trials specifically targeting underage participants and 1625 studies dedicated to seniors."

Answered by AI

What is the approximate size of this medical trial's cohort?

"Yes, according to the clinicaltrials.gov website this trial is presently recruiting volunteers. The study was initially posted on September 9th 2022 and has recently been edited as of September 12th 2022. This research needs 20 participants from a single medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
2022. "A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540340.
All > T Cell Lymphoma
~3 spots leftby Sep 2024
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