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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zevalin-BuCyE
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Zevalin, B-cell non-Hodgkin's lymphoma, autologous stem cell transplantation, BuCyE regimen

Eligibility Criteria

undefined - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zevalin-BuCyE

Arm Description

histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.

Outcomes

Primary Outcome Measures

Event-free survival
Three year event-free survival rate would be reported.

Secondary Outcome Measures

Overall survival
Three year overall survival would be reported.
Toxicity of the treatment combination
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.

Full Information

First Posted
June 13, 2006
Last Updated
February 13, 2016
Sponsor
Asan Medical Center
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00336843
Brief Title
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Zevalin, B-cell non-Hodgkin's lymphoma, autologous stem cell transplantation, BuCyE regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zevalin-BuCyE
Arm Type
Experimental
Arm Description
histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
Intervention Type
Drug
Intervention Name(s)
Zevalin-BuCyE
Intervention Description
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 Outcome Measure Information:
Title
Event-free survival
Description
Three year event-free survival rate would be reported.
Time Frame
the time from stem cell infusion to failure or death from any cause
Secondary Outcome Measure Information:
Title
Overall survival
Description
Three year overall survival would be reported.
Time Frame
from stem cell infusion to death of any cause or last follow-up
Title
Toxicity of the treatment combination
Description
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.
Time Frame
any toxicity due to study treatment during study period

10. Eligibility

Sex
All
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolwon Suh, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, Departement of Internal Medicine, Division of Oncology
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19547918
Citation
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. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23.
Results Reference
result

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

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