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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969435
• Other study ID #: 201312115
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2013
• Last updated: January 16, 2018
• Start date: March 19, 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2017
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. .

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Carmustine

• Etoposide phosphate

• Cytarabine

• Melphalan HCl (propylene glycol-free)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day -7 through Day 30
Primary	Treatment-related Mortality (TRM)	TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant	100 days
Secondary	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	Up to Day 100
Secondary	Disease-free Survival	Percentage of patients who survive without any signs or symptoms of cancer at 1 year.	1 year
Secondary	Disease-free Survival	Percentage of patients who survive without any signs or symptoms of cancer at 2 years.	2 years
Secondary	Time to Engraftment (Neutrophil)	Time from the date of the transplant to the date of neutrophil engraftment.	Assessed up to day 30
Secondary	Time to Engraftment (Platelet)	Time from the date of transplant to the date of platelet engraftment.	Assessed up to day 100

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine