BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma

Non-hodgkin Lymphoma Clinical Trial

— CISL  

Official title:

Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794167
• Other study ID #: CISL 12-05
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2012
• Est. completion date: November 30, 2018

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 comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Description:

Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies.

The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL.

Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2018
• Est. primary completion date: May 30, 2017
• 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 or high risk NHL with remission in induction chemotherapy

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 Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jong-Ho Won	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 progression free survival	calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death	2 years
Secondary	Rate of overall survival	calculate from the date of ASCT until the time of death from any causes	2 years
Secondary	Rate of regimen related toxicity	calculate toxicities frequency	6 months