Back to results90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
Primary Purpose
Lymphoma, Large B-Cell, Diffuse
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ibritumomab tiuxetan (Zevalin)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring bulky diffuse large B cell lymphoma, 90Y-ibritumomab tiuxetan, clinical response, Safety and toxicity
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed CD20+ DLBCL
- Patients with stage I/II
- Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm)
- Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy
- Aged over 18 years
- ECOG performance status 0-2.
Exclusion Criteria:
- Previous history of chemotherapy for diffuse large B cell lymphoma
- Prior myeloablative therapy
- Prior external-beam radiation to >25% of active bone marrow
- Pregnancy and lactation
- >25% bone marrow infiltration
- Platelet counts <100 000/µl, neutrophil counts <1500/µl
- Children and adolescents under 18 years of age
- Presence of CNS involvement with diffuse large B cell lymphoma
- Positive HIV serology
- Seriously uncontrolled, current infections or other concomitant
Sites / Locations
- Chonnam National University Hwasun Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ibritumomab tuixetan, response, toxicity
Arm Description
Outcomes
Primary Outcome Measures
Objective response
Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.
Safety and toxicity
After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.
Secondary Outcome Measures
Progression-free survival
Full Information
NCT ID
NCT01157988
First Posted
July 6, 2010
Last Updated
July 7, 2010
Sponsor
Chonnam National University Hospital
Collaborators
Samsung Medical Center, Asan Medical Center, Chonbuk National University Hospital, Dong-A University Hospital, Pusan National University Hospital, Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01157988
Brief Title
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
Official Title
Phase II Study of 90Y-ibritumomab Tiuxetan Treatment as a Consolidation After 6th R-CHOP Chemotherapy in Patients With Limited-stage, Bulky Diffuse Large B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Samsung Medical Center, Asan Medical Center, Chonbuk National University Hospital, Dong-A University Hospital, Pusan National University Hospital, Severance Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).
Detailed Description
The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse
Keywords
bulky diffuse large B cell lymphoma, 90Y-ibritumomab tiuxetan, clinical response, Safety and toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibritumomab tuixetan, response, toxicity
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ibritumomab tiuxetan (Zevalin)
Intervention Description
During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count > 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.
Primary Outcome Measure Information:
Title
Objective response
Description
Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.
Time Frame
Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
Title
Safety and toxicity
Description
After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.
Time Frame
3 years after the infusion of 90Y-ibritumomab tiuxetan
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
the time from start of R-CHOP to the first recording of disease progression or death of any cause
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed CD20+ DLBCL
Patients with stage I/II
Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm)
Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy
Aged over 18 years
ECOG performance status 0-2.
Exclusion Criteria:
Previous history of chemotherapy for diffuse large B cell lymphoma
Prior myeloablative therapy
Prior external-beam radiation to >25% of active bone marrow
Pregnancy and lactation
>25% bone marrow infiltration
Platelet counts <100 000/µl, neutrophil counts <1500/µl
Children and adolescents under 18 years of age
Presence of CNS involvement with diffuse large B cell lymphoma
Positive HIV serology
Seriously uncontrolled, current infections or other concomitant
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22035417
Citation
Yang DH, Kim WS, Kim SJ, Kim JS, Kwak JY, Chung JS, Oh SY, Suh C, Lee JJ. Pilot trial of yttrium-90 ibritumomab tiuxetan consolidation following rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy in patients with limited-stage, bulky diffuse large B-cell lymphoma. Leuk Lymphoma. 2012 May;53(5):807-11. doi: 10.3109/10428194.2011.635857. Epub 2011 Dec 7.
Results Reference
derived
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90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
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