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

Soon Chun Hyang University

Status and phase: Completed; Phase 2

Conditions: Non-hodgkin Lymphoma

Treatments: Drug: Melphalan; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Busulfan

Study type: Interventional

Funder types: Other

Identifiers

NCT03794167

CISL 12-05

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

busulfan cyclophosphamide etoposide

Experimental group

Description:

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

Treatment:

Drug: Etoposide

Drug: Busulfan

Drug: Cyclophosphamide

busulfan melphalan etoposide

Active Comparator group

Description:

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

Treatment:

Drug: Etoposide

Drug: Busulfan

Drug: Melphalan