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NCT Number: NCT01157988

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

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).

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Key information

Conditions

Lymphoma, Large B-Cell, Diffuse Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-809, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibritumomab Tiuxetan (Zevalin)

Drug

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 outcomes

  1. Objective response

    Time frame: Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan

    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.

  2. Safety and toxicity

    Time frame: 3 years after the infusion of 90Y-ibritumomab tiuxetan

    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 outcomes

  1. Progression-free survival

    Time frame: the time from start of R-CHOP to the first recording of disease progression or death of any cause

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Asan Medical Center
  • Chonbuk National University Hospital
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Samsung Medical Center
  • Severance Hospital

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
First posted
Jul 8, 2010
Registry last updated
Jul 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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