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

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ClinicalTrials.gov Identifier: NCT03794167
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jong-Ho Won, Soonchunhyang University Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-hodgkin Lymphoma Drug: Busulfan Drug: Cyclophosphamide Drug: Etoposide Drug: Melphalan Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 1, 2012
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : November 30, 2018


Arm Intervention/treatment
Experimental: busulfan cyclophosphamide etoposide
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
Drug: Busulfan
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
Other Name: Busulfex

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

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

Active Comparator: busulfan melphalan etoposide
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
Drug: Busulfan
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
Other Name: Busulfex

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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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 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 -

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): NCT03794167


Locations
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Korea, Republic of
Jong-Ho Won
Seoul, Korea, Republic of, 04401
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: NCT03794167     History of Changes
Other Study ID Numbers: CISL 12-05
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Cyclophosphamide
Melphalan
Busulfan
Etoposide
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors