Status:
COMPLETED
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Lymphoma
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
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 the...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00690560
Start Date
May 1 2007
End Date
October 1 2010
Last Update
September 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Antoine Lacassagne
Nice, France, 06189