90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma

Lymphoma, Large B-Cell, Diffuse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157988
• Other study ID #: CISL-2007
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2010
• Last updated: July 7, 2010
• Start date: January 2007

Study information

• Verified date: April 2006
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• ibritumomab tiuxetan (Zevalin)
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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do

Sponsors (7)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Asan Medical Center, Chonbuk National University Hospital, Dong-A University Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan	No
Primary	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.	3 years after the infusion of 90Y-ibritumomab tiuxetan	Yes
Secondary	Progression-free survival		the time from start of R-CHOP to the first recording of disease progression or death of any cause	No