Clinical trial NCT01157988: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: bulky diffuse large B cell lymphoma
90Y-ibritumomab tiuxetan
clinical response
Safety and toxicity
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Asan Medical Center
name: Chonbuk National University Hospital
name: Dong-A University Hospital
name: Pusan National University Hospital
name: Severance Hospital
First posted: 2010-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response
timeFrame: Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
measure: Safety and toxicity
timeFrame: 3 years after the infusion of 90Y-ibritumomab tiuxetan
Secondary outcomes:
measure: Progression-free survival
timeFrame: the time from start of R-CHOP to the first recording of disease progression or death of any cause
Other outcomes:
Locations:
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
Study officials:
References:
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.