NCT01157988

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
Last Updated

July 8, 2010

Status Verified

April 1, 2006

Enrollment Period

2 years

First QC Date

July 6, 2010

Last Update Submit

July 7, 2010

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

bulky diffuse large B cell lymphoma90Y-ibritumomab tiuxetanclinical responseSafety and toxicity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Progression-free survival

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

Study Arms (1)

ibritumomab tuixetan, response, toxicity

EXPERIMENTAL
Drug: ibritumomab tiuxetan (Zevalin)

Interventions

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.

ibritumomab tuixetan, response, toxicity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

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

Location

Related Publications (1)

  • 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.

    PMID: 22035417DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 8, 2010

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Last Updated

July 8, 2010

Record last verified: 2006-04

Locations

KR(1)