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NCT Number: NCT00690560

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

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.

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Key information

Conditions

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

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Antoine Lacassagne

Nice, 06189, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Biological

Cyclophosphamide

Drug

Doxorubicin hydrochloride

Drug

Prednisone

Drug

vincristine sulfate

Drug

yttrium Y 90 ibritumomab tiuxetan

Radiation

Primary outcomes

  1. Event-free Survival

    Time frame: 2 years

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years

  2. Relapse-free Survival in Responding Patients

    Time frame: 2 years

  3. Response Rate at the End of Treatment

    Time frame: up to six months

    Complete Response 60% (N=15) Partial Response 8% (N=2) Missing data 32% (N=8)

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study title

International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2008
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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