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Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

Primary Purpose

Hodgkin Disease, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carmustine
Etoposide phosphate
Cytarabine
Melphalan HCl (propylene glycol-free)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
  • Eligible for autologous stem cell transplantation.
  • 18 to 75 years of age at time of enrollment.
  • Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient body weight
  • ECOG performance status ≤ 2

  • Normal organ function as defined below:

    • Creatinine clearance > 40 ml/min
    • Total bilirubin ≤2.0 x IULN
    • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
    • LVEF > 40% (by ECHO or MUGA)
    • FEV1 > 50% of predicted and DLCO > or = 50% of predicted
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
  • Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melphalan, carmustine, etoposide, cytarabine (BEAM)

Arm Description

Day -7, carmustine intravenous (IV) infusion Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day Day -2, melphalan HCl (propylene glycol-free)(IV) infusion Day 0, stem cell transplant.

Outcomes

Primary Outcome Measures

Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Treatment-related Mortality (TRM)
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant

Secondary Outcome Measures

Efficacy as Measured by Response Rates
The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion. Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 1 year.
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 2 years.
Time to Engraftment (Neutrophil)
Time from the date of the transplant to the date of neutrophil engraftment.
Time to Engraftment (Platelet)
Time from the date of transplant to the date of platelet engraftment.

Full Information

First Posted
October 16, 2013
Last Updated
January 16, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01969435
Brief Title
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Official Title
A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 19, 2014 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease, Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melphalan, carmustine, etoposide, cytarabine (BEAM)
Arm Type
Experimental
Arm Description
Day -7, carmustine intravenous (IV) infusion Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day Day -2, melphalan HCl (propylene glycol-free)(IV) infusion Day 0, stem cell transplant.
Intervention Type
Drug
Intervention Name(s)
Carmustine
Other Intervention Name(s)
BCNU, BiCNU®
Intervention Type
Drug
Intervention Name(s)
Etoposide phosphate
Other Intervention Name(s)
VP-16, Vepesid
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside, Ara-C
Intervention Type
Drug
Intervention Name(s)
Melphalan HCl (propylene glycol-free)
Primary Outcome Measure Information:
Title
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Description
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Time Frame
Day -7 through Day 30
Title
Treatment-related Mortality (TRM)
Description
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Efficacy as Measured by Response Rates
Description
The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion. Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
Time Frame
Up to Day 100
Title
Disease-free Survival
Description
Percentage of patients who survive without any signs or symptoms of cancer at 1 year.
Time Frame
1 year
Title
Disease-free Survival
Description
Percentage of patients who survive without any signs or symptoms of cancer at 2 years.
Time Frame
2 years
Title
Time to Engraftment (Neutrophil)
Description
Time from the date of the transplant to the date of neutrophil engraftment.
Time Frame
Assessed up to day 30
Title
Time to Engraftment (Platelet)
Description
Time from the date of transplant to the date of platelet engraftment.
Time Frame
Assessed up to day 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma. Eligible for autologous stem cell transplantation. 18 to 75 years of age at time of enrollment. Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient body weight ECOG performance status ≤ 2 Normal organ function as defined below: Creatinine clearance > 40 ml/min Total bilirubin ≤2.0 x IULN AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN LVEF > 40% (by ECHO or MUGA) FEV1 > 50% of predicted and DLCO > or = 50% of predicted Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Able to understand and willing to sign an IRB approved written informed consent document. Exclusion Criteria: A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry. Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Cashen, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

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