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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2006

Last Updated Date

February 7, 2011

Start Date ^ICMJE

November 2005

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Event free survival

Change History

Complete list of historical versions of study NCT00336843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Overall survival
Response rate
Toxicity of the treatment combination

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00336843

Other Study ID Numbers ^ICMJE

AMC 2005-276

Has Data Monitoring Committee

Yes

Responsible Party

Chairman, IRB, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Schering-Plough

Investigators ^ICMJE

Principal Investigator:

Cheolwon Suh, MD, PhD

Asan Medical Center

Information Provided By

Asan Medical Center

Verification Date

November 2008

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

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