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
65 Years
80 Years
Both
Lymphoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival
Safety Issue:
No
Principal Investigator
Frederec Peyrade, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Antoine Lacassagne
Authority:
Unspecified
Study ID:
CDR0000589530
NCT ID:
NCT00690560
Start Date:
May 2007
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
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