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

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ClinicalTrials.gov Identifier: NCT03792815
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jong-Ho Won, Soonchunhyang University Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Busulfan Drug: Melphalan Drug: Etoposide Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : September 2013


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 Name: Busulfex

Drug: Melphalan
melphalan 50mg/m2/day i.v. on day -3 and -2
Other Name: Alkeran

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792815


Locations
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Korea, Republic of
Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-743
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jong-Ho Won, Professor Soonchunhyang University Hospital

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Responsible Party: Jong-Ho Won, professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT03792815     History of Changes
Other Study ID Numbers: SCH HMO
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jong-Ho Won, Soonchunhyang University Hospital:
Transplantation Conditioning

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Etoposide phosphate
Melphalan
Busulfan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs