BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma

NCT02836639 | Unknown Phase 2 DMC

• 1 other identifier: BEB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  1 year after ASCT

• Progression-free survival

  3 years after ASCT

Secondary Outcomes (3)

• Overall survival

  1 year and 3 year after ASCT

• Complete response rate

  1 year and 3 year after ASCT

• Incidence of adverse events

  1 year and 3 year after ASCT

Study Arms (1)

Busulfan, Etoposide, Bendamustine

EXPERIMENTAL

All patients will receive the conditioning regimen followed by autologous stem cell transplantation.

Drug: Busulfan; Drug: Etoposide; Drug: Bendamustine

Interventions

Busulfan DRUG

Busulfan 0.8 mg/kg four times per day from day -7 to day -5

Busulfan, Etoposide, Bendamustine

Etoposide DRUG

Etoposide 400 mg/m2 from day -5 to day -4

Busulfan, Etoposide, Bendamustine

Bendamustine DRUG

Bendamustine 200 mg/m2 starting dose on day -3 and -2

Busulfan, Etoposide, Bendamustine

Eligibility Criteria

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

You may qualify if:

• Patients with histologically diagnosed non-Hodgkin's lymphoma
• ≤ Age ≤ 65 years
• Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
• Adequate kidney function with serum creatinine\< 2.0 mg/dL
• Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit.
• Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL
• Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients
• Candidate for ASCT

You may not qualify if:

• Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator
• Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
• Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)\<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders
• Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
• Allergic to the investigational drug
• Patients who have difficulty understanding the informed consent form or patients who did not give consent
• Serum bilirubin upper than 2 times the normal upper limit
• Major surgery procedure within 30 days prior to start of investigational treatment
• Patients vaccinated against yellow fever

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

RECRUITING

Related Publications (2)

• Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.

  PMID: 21816830 BACKGROUND

• Shin HJ, Lee WS, Lee HS, Kim H, Lee GW, Song MK, Kim JS, Yhim HY, Chung JS. Busulfan-containing conditioning regimens are optimal preparative regimens for autologous stem cell transplant in patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2014 Nov;55(11):2490-6. doi: 10.3109/10428194.2014.882504. Epub 2014 Mar 7.

  PMID: 24432893 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Busulfan; Etoposide; Bendamustine Hydrochloride

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)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hojin Shin

  Pusan National Universty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieon Lee

CONTACT

+82-51-240-7053; jieon@pnuh.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor department of hematooncology

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 19, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2019
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)