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

This study has been completed.
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Chonbuk National University Hospital
Dong-A University Hospital
Pusan National University Hospital
Severance Hospital
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01157988
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: April 2006
  Purpose

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).


Condition Intervention Phase
Lymphoma, Large B-Cell, Diffuse
Drug: ibritumomab tiuxetan (Zevalin)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Objective response [ Time Frame: Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years after the infusion of 90Y-ibritumomab tiuxetan ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: the time from start of R-CHOP to the first recording of disease progression or death of any cause ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ibritumomab tuixetan, response, toxicity 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157988

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Sponsors and Collaborators
Chonnam National University Hospital
Samsung Medical Center
Asan Medical Center
Chonbuk National University Hospital
Dong-A University Hospital
Pusan National University Hospital
Severance Hospital
  More Information

No publications provided by Chonnam National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Je-Jung Lee, Chonnam National Hwasun Hospital
ClinicalTrials.gov Identifier: NCT01157988     History of Changes
Other Study ID Numbers: CISL-2007
Study First Received: July 6, 2010
Last Updated: July 7, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
bulky diffuse large B cell lymphoma
90Y-ibritumomab tiuxetan
clinical response
Safety and toxicity

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014