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

NCT00690560 | Completed Phase 2

• 5 other identifiers: 2006/27CALACASS-3RCHOPZINCA-RECF06242006-006179-19CALACASS-2006/27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  1 year

Secondary Outcomes (5)

• Overall survival

  up to one year

• Relapse-free survival in responding patients

  up to one year

• Rate of disease progression

  up to 2 years

• Response rate

  up to six months

• Toxicities

  up to 2 years

Study Arms (1)

R-CHOP14 chemotherapy

EXPERIMENTAL

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

Interventions

rituximab BIOLOGICAL

R-CHOP14 chemotherapy

cyclophosphamide DRUG

R-CHOP14 chemotherapy

doxorubicin hydrochloride DRUG

R-CHOP14 chemotherapy

prednisone DRUG

R-CHOP14 chemotherapy

vincristine sulfate DRUG

R-CHOP14 chemotherapy

yttrium Y 90 ibritumomab tiuxetan RADIATION

R-CHOP14 chemotherapy

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Frederec Peyrade, MD

  Centre Antoine Lacassagne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 4, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 30, 2025

Record last verified: 2015-02

Locations

FR (1)