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

NCT01969435 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201312115
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• Treatment-related Mortality (TRM)

  TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant

  100 days

Secondary Outcomes (5)

• Efficacy as Measured by Response Rates

  Up to Day 100

• Disease-free Survival

  1 year

• Disease-free Survival

  2 years

• Time to Engraftment (Neutrophil)

  Assessed up to day 30

• Time to Engraftment (Platelet)

  Assessed up to day 100

Study Arms (1)

Melphalan, carmustine, etoposide, cytarabine (BEAM)

EXPERIMENTAL

* 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.

Drug: Carmustine; Drug: Etoposide phosphate; Drug: Cytarabine; Drug: Melphalan HCl (propylene glycol-free)

Interventions

Carmustine DRUG

Also known as: BCNU, BiCNU®

Melphalan, carmustine, etoposide, cytarabine (BEAM)

Etoposide phosphate DRUG

Also known as: VP-16, Vepesid

Melphalan, carmustine, etoposide, cytarabine (BEAM)

Cytarabine DRUG

Also known as: Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside, Ara-C

Melphalan, carmustine, etoposide, cytarabine (BEAM)

Melphalan HCl (propylene glycol-free) DRUG

Melphalan, carmustine, etoposide, cytarabine (BEAM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
• Eligible for autologous stem cell transplantation.
• 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.

You may not qualify if:

• 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. .

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Carmustine; etoposide phosphate; Etoposide; Cytarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Amanda F. Cashen, M.D.
• Organization: Washington University School of Medicine

acashen@wustl.edu

314-454-8304

Study Officials

• Amanda Cashen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 25, 2013
• Study Start: March 19, 2014
• Primary Completion: September 30, 2015
• Study Completion: May 31, 2017
• Last Updated: February 13, 2018
• Results First Posted: November 11, 2016

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)