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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00690560
First received: June 3, 2008
Last updated: December 13, 2009
Last verified: July 2009

June 3, 2008
December 13, 2009
May 2007
March 2010   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690560 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Relapse-free survival in responding patients [ Designated as safety issue: No ]
  • Rate of disease progression [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Toxicities [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
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

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
63
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
65 Years to 80 Years
No
France
 
NCT00690560
CDR0000589530, CALACASS-3RCHOPZ, INCA-RECF0624, EUDRACT-2006-006179-19, CALACASS-2006/27
Not Provided
Not Provided
Centre Antoine Lacassagne
Not Provided
Study Chair: Frederec Peyrade, MD Centre Antoine Lacassagne
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP