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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lymphoma, Large B-Cell, Diffuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ibritumomab tuixetan, response, toxicity

Group Type EXPERIMENTAL

ibritumomab tiuxetan (Zevalin)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No