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

Phase 2

Completed

• Conditions: Non-hodgkin Lymphoma
• Interventions: Drug: Busulfan; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Melphalan

• Registration Number: NCT03794167
• Lead Sponsor: Soonchunhyang University Hospital

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.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2017-05-30
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
busulfan melphalan etoposide	Melphalan	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
busulfan cyclophosphamide etoposide	Cyclophosphamide	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
busulfan cyclophosphamide etoposide	Busulfan	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
busulfan melphalan etoposide	Busulfan	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
busulfan melphalan etoposide	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
busulfan cyclophosphamide etoposide	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

Primary Outcome Measures

Name	Time	Method
Rate of progression free survival	2 years	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

Secondary Outcome Measures

Name	Time	Method
Rate of regimen related toxicity	6 months	calculate toxicities frequency
Rate of overall survival	2 years	calculate from the date of ASCT until the time of death from any causes

Trial Locations

Locations (1)

Jong-Ho Won; 🇰🇷 Seoul, Korea, Republic of