Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)

Non-Hodgkin's Lymphoma Clinical Trial

— BME  

Official title:

Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792815
• Other study ID #: SCH HMO
• Status: Completed
• Phase: Phase 2
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: January 2019
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Description:

Treatment:

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria

1. Histologically confirmed aggressive NHL

2. Mantle cell lymphoma

3. salvage chemotherapy sensitive relapse/refractory NHL

4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.

5. Age; 18-65

6. Adequate renal function: serum creatinine = 1.5mg/dL

7. Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value

Exclusion criteria

1. low grade NHL

2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri

3. Other serious illness or medical conditions

• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry

• History of significant neurological or psychiatric disorders

• Active uncontrolled infection (viral, bacterial or fungal infection)

4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception

5. HIV (+)

6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Busulfan
busulfan 3.2mg/kg iv on day -8, -7, and -6,
• Melphalan
melphalan 50mg/m2/day i.v. on day -3 and -2
• Etoposide
etoposide 400 mg/m2 i.v. on day -5 and -4

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of event free survival	calculate from the date of ASCT until the time of disease progression, relapse, or death	from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years
Secondary	rate of event free survival	calculate from the date of ASCT until the time of death from any causes	at least 2 years
Secondary	rate of regimen related toxicity	calculate toxicities	up to 6 months