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Completed

NCT Number: NCT03792815

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soonchunhyang University Hospital

Seoul, 140-743, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed aggressive NHL
  • Mantle cell lymphoma
  • salvage chemotherapy sensitive relapse/refractory NHL
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Age; 18-65
  • Adequate renal function: serum creatinine ≤ 1.5mg/dL
  • Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value

Exclusion criteria

  • low grade NHL
  • Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  • 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)
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • HIV (+)
  • 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

Treatment and study plan

busulfan

Drug

busulfan 3.2mg/kg iv on day -8, -7, and -6,

Other names: Busulfex

melphalan

Drug

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

Other names: Alkeran

etoposide

Drug

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

Primary outcomes

  1. rate of event free survival

    Time frame: from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years

    calculate from the date of ASCT until the time of disease progression, relapse, or death

Secondary outcomes

  1. rate of event free survival

    Time frame: at least 2 years

    calculate from the date of ASCT until the time of death from any causes

  2. rate of regimen related toxicity

    Time frame: up to 6 months

    calculate toxicities

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Acronym: BME

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jan 3, 2019
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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