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

Primary Purpose

Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pharmacokinetics

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Pharmacokinetics, Carmustine, Etoposide, Melphalan, Cytarabine, 22-086

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacokinetic directed melphalan

Arm Description

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.

Outcomes

Primary Outcome Measures

determine if this target AUC can be achieved

within a range of 8.5 (+/- 1.5) mg*h/L using population PK model.

Secondary Outcome Measures

Full Information

NCT ID

NCT05540340

First Posted

September 12, 2022

Last Updated

January 3, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05540340

Brief Title

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

Official Title

Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 9, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population PK model) in BEAM chemotherapy before AHCT. Standard dose is fixed for everybody and is calculated using height and weight. The population PK model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. Study researchers think that the dose calculated using the population PK model may still be effective but have less side effects than the standard melphalan dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin

Keywords

Pharmacokinetics, Carmustine, Etoposide, Melphalan, Cytarabine, 22-086

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pharmacokinetic directed melphalan

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Pharmacokinetics

Intervention Description

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.

Primary Outcome Measure Information:

Title

determine if this target AUC can be achieved

Description

within a range of 8.5 (+/- 1.5) mg*h/L using population PK model.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Parastoo Dahi, MD

Phone

646-608-3733

dahip@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Gunjan Shah, MD

Phone

646-608-3734

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parastoo Dahi, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parastoo Dahi, MD

Phone

646-608-3733

First Name & Middle Initial & Last Name & Degree

Gunjan Shah, MD

Phone

646-608-3734

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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

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