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

NCT ID: NCT01969435

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-19
• Study Completion Date: 2017-05-31

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

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melphalan, carmustine, etoposide, cytarabine (BEAM)

• 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.

Group Type: EXPERIMENTAL

Carmustine

Intervention Type: DRUG

Etoposide phosphate

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Melphalan HCl (propylene glycol-free)

Intervention Type: DRUG

Interventions

Carmustine

Intervention Type: DRUG

Etoposide phosphate

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Melphalan HCl (propylene glycol-free)

Intervention Type: DRUG

Other Intervention Names

BCNU; BiCNU®; VP-16; Vepesid; Cytosar-U ®; 1-β-Arabinofuranosylcytosine; Arabinosylcytosine; Cytosine arabinoside; Ara-C

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. .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Cashen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201312115

Identifier Type: -

Identifier Source: org_study_id