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NCT Number: NCT03794167

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

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).

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Key information

Conditions

Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jong-Ho Won

Seoul, 04401, South Korea

About this study

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.

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 or high risk NHL with remission in induction chemotherapy
  • 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 3.2 mg/kg/day i.v. on days -8,-7, and -6

Other names: Busulfex

Cyclophosphamide

Drug

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

etoposide

Drug

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

melphalan

Drug

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

Other names: Alkeran

Primary outcomes

  1. Rate of progression free survival

    Time frame: 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 outcomes

  1. Rate of overall survival

    Time frame: 2 years

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

  2. Rate of regimen related toxicity

    Time frame: 6 months

    calculate toxicities frequency

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma

Acronym: CISL

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jan 4, 2019
Registry last updated
Jan 7, 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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