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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836639
• Other study ID #: BEB
• Status: Recruiting
• Phase: Phase 2
• First received: June 27, 2016
• Last updated: July 14, 2016
• Start date: February 2016

Study information

• Verified date: July 2016
• Source: Pusan National University Hospital
• Contact: Jieon Lee
• Phone: +82-51-240-7053
• Email: jieon[@]pnuh.co.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with histologically diagnosed non-Hodgkin's lymphoma

2. 16 = Age = 65 years

3. Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)

4. Adequate kidney function with serum creatinine< 2.0 mg/dL

5. 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.

6. Adequate bone marrow function with absolute neutrophil count = 1,500/µL; platelets = 75,000/µL; hemoglobin = 9.0 g/dL

7. Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients

8. Candidate for ASCT

Exclusion Criteria:

1. 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

2. 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.

3. 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

4. Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)

5. Allergic to the investigational drug

6. Patients who have difficulty understanding the informed consent form or patients who did not give consent

7. Serum bilirubin upper than 2 times the normal upper limit

8. Major surgery procedure within 30 days prior to start of investigational treatment

9. Patients vaccinated against yellow fever

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Busulfan
Busulfan 0.8 mg/kg four times per day from day -7 to day -5
• Etoposide
Etoposide 400 mg/m2 from day -5 to day -4
• Bendamustine
Bendamustine 200 mg/m2 starting dose on day -3 and -2

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		1 year after ASCT	No
Primary	Progression-free survival		3 years after ASCT	No
Secondary	Overall survival		1 year and 3 year after ASCT	No
Secondary	Complete response rate		1 year and 3 year after ASCT	No
Secondary	Incidence of adverse events		1 year and 3 year after ASCT	Yes