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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00336843
First received: June 13, 2006
Last updated: February 7, 2011
Last verified: November 2008

June 13, 2006
February 7, 2011
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 ] [ Designated as safety issue: No ]
Three year event-free survival rate would be reported.
Event free survival
Complete list of historical versions of study NCT00336843 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: from stem cell infusion to death of any cause or last follow-up ] [ Designated as safety issue: No ]
    Three year overall survival would be reported.
  • Toxicity of the treatment combination [ Time Frame: any toxicity due to study treatment during study period ] [ Designated as safety issue: Yes ]
    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

Treatment:

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Other Name: Zevalin-BuCyE
Not Provided
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. Epub 2009 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
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
Both
up to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00336843
AMC 2005-276
Yes
Chairman, IRB, Asan Medical Center
Asan Medical Center
Schering-Plough
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
Asan Medical Center
November 2008

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