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NCT Number: NCT00336843

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center, Departement of Internal Medicine, Division of Oncology

Seoul, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zevalin-BuCyE

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Overall survival

    Time frame: from stem cell infusion to death of any cause or last follow-up

    Three year overall survival would be reported.

  2. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Schering-Plough

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jun 14, 2006
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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