Autologous Stem Cell Transplantation (ASCT) With Zevalin Plus Busulfan, Cyclophosphamide and Etoposide (BuCyE) in B-Cell Non-Hodgkin's Lymphoma (NHL) - Full Text View

Sponsors and Collaborators:	Asan Medical Center Schering-Plough
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00336843

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 Drug: Busulfan Drug: Cyclophosphamide Drug: Etoposide	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Etoposide Rituximab Etoposide phosphate Ibritumomab tiuxetan Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Event-free survival [ Time Frame: from ASCT to any event ] [ Designated as safety issue: No ]

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 ]
Toxicity of the treatment combination [ Time Frame: any toxicity due to study treatment during study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Z-BuCyE conditioning	Drug: Zevalin 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. etoposide Drug: Busulfan Day 7, 6, 5: Busulfan 3.2 mg/kg I.V. Drug: Cyclophosphamide Day 3, 2: Cytoxan 50 mg/kg I.V. Drug: Etoposide Day 5, 4: Etoposide 200 mg/m2 I.V. every 12 hours

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 < 3 X 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

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

Responsible Party:	IRB, Asan Medical Center ( Chairman )
Study ID Numbers:	AMC 2005-276
Study First Received:	June 13, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00336843
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

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Cyclophosphamide
Etoposide phosphate
Lymphoma, B-Cell
Lymphatic Diseases

B-cell lymphomas
Busulfan
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Etoposide

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009