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Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma

This study has been completed.
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center Identifier:
First received: June 13, 2006
Last updated: February 13, 2016
Last verified: February 2016
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Zevalin-BuCyE
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: the time from stem cell infusion to failure or death from any cause ]
    Three year event-free survival rate would be reported.

Secondary Outcome Measures:
  • Overall survival [ Time Frame: from stem cell infusion to death of any cause or last follow-up ]
    Three year overall survival would be reported.

  • Toxicity of the treatment combination [ Time Frame: any toxicity due to study treatment during study period ]
    Adverse events would be assessed and graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 3.0. And the frequency of each grade would be reported as case number and proportion.

Enrollment: 19
Study Start Date: November 2005
Study Completion Date: May 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zevalin-BuCyE
histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
Drug: Zevalin-BuCyE
rituximab (IV, 250 mg/m2 on days −21 and −14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day −14) Busulfan (IV, 0.8 mg/kg every 6 h from day −7 to day −5) Cyclophosphamide (IV, 50 mg/kg on days −3 and −2) Etoposide (IV, 200 mg/m2 every 12 h on days −5 and −4) Autologous stem cells infusion on day 0

Detailed Description:

Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.

Study design: Prospective, multicenter, open-labeled, phase II trial.

Study objectives:

  • Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
  • Secondary: overall survival response rate toxicity of the treatment combination


Z-BuCyE Regimen

  • Day 21: rituximab, 250 mg/m2, I.V.
  • Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
  • Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
  • Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
  • Day 3, 2: Cytoxan 50 mg/kg I.V.
  • Day 0: autologous stem cell infusion

Ages Eligible for Study:   up to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
  • Age < 65 years old
  • WHO performance status (PS) of 0-2
  • ANC > 1,500/mm3, platelet > 100,000/mm3
  • Cr < 2.0 mg% or Ccr > 50 mL/min
  • Transaminase < 3X upper normal value
  • Bilirubin < 2 mg/dL
  • Life expectancy of at least 3 months
  • Written informed consent
  • Optimal harvest of autologous stem cells (CD34+ cells > 5 million/kg plus 2 million/kg for back-up)

Exclusion Criteria:

  • Prior hematopoietic stem cell transplantation
  • Prior RIT
  • Prior external radiation to > 25% of active bone marrow
  • CNS involvement of non-Hodgkin's lymphoma
  • Serious comorbid diseases
  • HIV or HTLV-1 associated malignancy
  • History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
  • Known hypersensitivity to murine antibodies/proteins
  • Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
  • Persistent toxic side effects from prior therapy
  • Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
  • Investigational drugs less than 4 weeks prior to entry on this study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00336843

Korea, Republic of
Asan Medical Center, Departement of Internal Medicine, Division of Oncology
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
  More Information

Responsible Party: Cheolwon Suh, ASCT team, Asan Medical Center Identifier: NCT00336843     History of Changes
Other Study ID Numbers: AMC 2005-276
Study First Received: June 13, 2006
Last Updated: February 13, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Asan Medical Center:
B-cell non-Hodgkin's lymphoma
autologous stem cell transplantation
BuCyE regimen

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017