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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336843
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center

June 13, 2006
June 14, 2006
February 17, 2016
November 2005
February 2009   (Final data collection date for primary outcome measure)
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.
Event-free survival
Complete list of historical versions of study NCT00336843 on Archive Site
  • 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.
  • Overall survival
  • Response rate
  • Toxicity of the treatment combination
Not Provided
Not Provided
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
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
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.

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
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
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
Experimental: Zevalin-BuCyE
histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
Intervention: Drug: Zevalin-BuCyE
Kang BW, Kim WS, Kim C, Jang G, Lee SS, Choi YH, Lee DH, Kim SW, Kim S, Ryu JS, Huh J, Lee JS, Suh C. Yttrium-90-ibritumomab tiuxetan in combination with intravenous busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Invest New Drugs. 2010 Aug;28(4):516-22. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2010
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 64 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
AMC 2005-276
Not Provided
Plan to Share IPD: No
Cheolwon Suh, Asan Medical Center
Asan Medical Center
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
Asan Medical Center
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP