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

NCT ID: NCT00690560

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-10-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP14 chemotherapy

Group Type: EXPERIMENTAL

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

yttrium Y 90 ibritumomab tiuxetan

Intervention Type: RADIATION

Interventions

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

yttrium Y 90 ibritumomab tiuxetan

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed large B-cell lymphoma

• Stage I, II, III, or IV disease
• Bone marrow or lymph node involvement by small cell lymphoma allowed
• No serious, progressive pathology (at investigator's discretion)
• CD20-positive disease
• Measurable disease
• No prior indolent lymphoma, treated or not
• No meningeal or CNS lymphoma

PATIENT CHARACTERISTICS:

• International prognostic index < 2 (adjusted for age)
• Life expectancy > 3 months
• ALT and AST ≤ 2.5 times upper limit of normal
• Bilirubin ≤ 30 mmol/L
• Creatinine ≤ 150 μmol/L
• HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
• No contraindication to chemotherapy or immunotherapy
• No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
• No contraindication to a venous catheter

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 30 days since prior and no other concurrent investigational treatment
• No prior therapy
• No concurrent participation in another clinical study

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederec Peyrade, MD

Role: STUDY_CHAIR

Centre Antoine Lacassagne

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Other Identifiers

CALACASS-3RCHOPZ

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0624

Identifier Type: -

Identifier Source: secondary_id

2006-006179-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CALACASS-2006/27

Identifier Type: -

Identifier Source: secondary_id

2006/27

Identifier Type: -

Identifier Source: org_study_id