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

NCT ID: NCT03794167

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2018-11-30

Brief 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).

Detailed 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.

Conditions

Non-hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

busulfan cyclophosphamide etoposide

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

Group Type: EXPERIMENTAL

Busulfan

Intervention Type: DRUG

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6

Cyclophosphamide

Intervention Type: DRUG

cyclophosphamide 50mg/kg/day i.v. on days -3 and -2

Etoposide

Intervention Type: DRUG

etoposide 400mg/m2 day i.v. on days -5 and -4

busulfan melphalan etoposide

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

Group Type: ACTIVE_COMPARATOR

Busulfan

Intervention Type: DRUG

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6

Etoposide

Intervention Type: DRUG

etoposide 400mg/m2 day i.v. on days -5 and -4

Melphalan

Intervention Type: DRUG

melphalan 50mg/m2/day i.v. on days -3 and -2

Interventions

Busulfan

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6

Intervention Type: DRUG

Cyclophosphamide

cyclophosphamide 50mg/kg/day i.v. on days -3 and -2

Intervention Type: DRUG

Etoposide

etoposide 400mg/m2 day i.v. on days -5 and -4

Intervention Type: DRUG

Melphalan

melphalan 50mg/m2/day i.v. on days -3 and -2

Intervention Type: DRUG

Other Intervention Names

Busulfex; Alkeran

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jong-Ho Won

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong-Ho Won, Professor

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

Jong-Ho Won

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CISL 12-05

Identifier Type: -

Identifier Source: org_study_id