Status:
UNKNOWN
Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Samsung Medical Center
Asan Medical Center
Conditions:
Lymphoma, Large B-cell, Diffuse
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse ...
Detailed Description
1. Four cycles of R-CHOP chemotherapy for the induction treatment \[Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)\] If patients with CCI \<1 * R...
Eligibility Criteria
Inclusion
- Histologically confirmed CD20 positive DLBCL
- Age ≥ 70
- Ann Arbor stage II, III and IV
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (Eastern Cooperative Oncology Group) ≤ 2
- At least one or more bidimensionally measurable lesion(s)
- ≥ 2 cm by conventional computerized tomography (CT)
- ≥ 1 cm by spiral CT
- skin lesion (photographs should be taken) ≥ 2 cm
- measurable lesion by physical examination ≥ 2 cm
- Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
- Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
- Adequate liver functions:
- Adequate bone marrow functions:
- hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
- Life expectancy more than 6 months
- Informed consent
Exclusion
- Other subtypes of non-Hodgkin's lymphoma
- Patients who transformed follicular lymphoma or other indolent lymphoma
- Primary Central Nervous System (CNS) DLBCL
- CNS involvement by lymphoma or any evidence of spinal cord compression.
- Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01181999
Start Date
August 1 2010
End Date
September 1 2014
Last Update
September 22 2011
Active Locations (1)
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1
Chonnam National University Hwasun Hosptial
Jeollanam-do, South Korea, 519-809