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
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ 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.


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)
Intervention Details:
    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
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

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
  Eligibility

Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336843

Locations
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
Schering-Plough
Investigators
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
  More Information

Publications:
Responsible Party: Chairman, IRB, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00336843     History of Changes
Other Study ID Numbers: AMC 2005-276
Study First Received: June 13, 2006
Last Updated: February 7, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014