Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: yttrium Y 90 ibritumomab tiuxetan

• Registration Number: NCT00690560
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.

Secondary

* Determine overall survival.

* Evaluate relapse-free survival for patients achieving complete or partial response.

* Determine the rate of disease progression.

* Determine response rate at the end of study therapy.

* Assess the toxicities of this regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.

Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.

* Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-CHOP14 chemotherapy	yttrium Y 90 ibritumomab tiuxetan	-
R-CHOP14 chemotherapy	cyclophosphamide	-
R-CHOP14 chemotherapy	rituximab	-
R-CHOP14 chemotherapy	vincristine sulfate	-
R-CHOP14 chemotherapy	doxorubicin hydrochloride	-
R-CHOP14 chemotherapy	prednisone	-

Primary Outcome Measures

Name	Time	Method
Event-free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to one year
Relapse-free survival in responding patients	up to one year
Toxicities	up to 2 years
Rate of disease progression	up to 2 years
Response rate	up to six months

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France