Status:
COMPLETED
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
Lead Sponsor:
Polish Lymphoma Research Group
Conditions:
Follicular Lymphoma
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS,...
Detailed Description
Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
Eligibility Criteria
Inclusion
- Histologically confirmed:
- Follicular lymphoma grade 1, 2, 3a
- Marginal zone lymphoma, including MALT type
- Small lymphocytic lymphoma (BM inv. \< 30%)
- Lymphoplasmacytic lymphoma
- Clinical stage II-IV (Ann Arbor). Stage I is allowed if bulky (Ø \> 7 cm) or if radiotherapy is not appropriate in judgment of treating physician
- Measurable lesion(s) in at least one site
- Patients previously untreated
- Patients presenting with symptoms requiring treatment:
- Progressive disease
- Symptoms related to tumor bulk
- Cytopenias related to bone marrow and/or spleen involvement B symptoms
- Age ≥ 18 years
- Performance status \</=2
- Written informed consent
Exclusion
- Grade 3b FL
- Transformed lymphoma
- CNS involvement
- Patient taking steroids for \> 2 weeks during last 4 weeks at a dose equivalent to ≥ 20 mg prednisone
- Other malignancy
- Major surgery within 4 weeks
- Hb \< 8 g/dl, ANC \< 1.5 x 109/L, Plt \<100 109/L unless due to lymphoma
- Impairment of renal function (creatinine \> 1.5 x UNV) or liver function (total bilirubin 1.5 x UNV, SGOT \> 2.5 x UNV not due to lymphoma
- Known infection, with HBV, HCV (acute \< 6 mos. or chronic hepatitis) or HIV
- Serious underlying medical conditions
- Life expectancy \< 6 months
- Known allergy to murine protein
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2017
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00801281
Start Date
February 1 2007
End Date
June 25 2017
Last Update
July 17 2017
Active Locations (12)
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1
Podkarpacki Oncology Centre
Brzozów, Poland, 36-200
2
Voivodeship Hospital, Oncology Ward
Elblag, Poland, 82-300
3
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
Gdansk, Poland, 80-211
4
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
Katowice, Poland, 40-029