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

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

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).

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Busulfan; Drug: Melphalan; Drug: Etoposide

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 140-743
    • Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: busulfan melphalan etoposide; 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	Drug: Busulfan; busulfan 3.2mg/kg iv on day -8, -7, and -6,; Other Names: Busulfex; Drug: Melphalan; melphalan 50mg/m2/day i.v. on day -3 and -2; Other Names: Alkeran; Drug: Etoposide; etoposide 400 mg/m2 i.v. on day -5 and -4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of event free survival	calculate from the date of ASCT until the time of death from any causes	at least 2 years
rate of regimen related toxicity	calculate toxicities	up to 6 months

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Jong-Ho Won, Professor, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Transplantation Conditioning
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Melphalan; Busulfan
• Other Study ID Numbers: SCH HMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED