First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
Overview[ - collapse ][ - ]
| Purpose | 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, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment. |
|---|---|
| Condition | Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma |
| Intervention | Drug: Rituximab, Cyclophosphamide, Vincristine, Prednisone Drug: Rituximab, Cyclophosphamid, Doxorubicin, Vincristine, Prednisone |
| Phase | Phase 3 |
| Sponsor | Polish Lymphoma Research Group |
| Responsible Party | Polish Lymphoma Research Group |
| ClinicalTrials.gov Identifier | NCT00801281 |
| First Received | December 2, 2008 |
| Last Updated | January 27, 2014 |
| Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 2, 2008 |
|---|---|
| Last Updated Date | January 27, 2014 |
| Start Date | February 2007 |
| Estimated Primary Completion Date | June 2017 |
| Current Primary Outcome Measures | Event Free Survival [Time Frame: +3 yrs] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Response Rate [Time Frame: +2 yrs] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. |
|---|---|
| Official Title | First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG. |
| 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, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment. |
| Detailed Description | Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Rituximab, Cyclophosphamide, Vincristine, Prednisone Rituximab 375 mg/m2 i.v. d. 1 Cyclophosphamide 750 mg/m2 i.v. d. 1 Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d. Drug: Rituximab, Cyclophosphamid, Doxorubicin, Vincristine, Prednisone Rituximab 375 mg/m2 i.v. d. 1, Cyclophosphamide 750 mg/m2 i.v. d. 1, Doxorubicin 50 mg/m2 i.v. d. 1, Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1, Prednisone 100 mg p.o. d. 1-5 q. 21 d. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 250 |
| Estimated Completion Date | June 2017 |
| Estimated Primary Completion Date | June 2014 |
| Eligibility Criteria | Inclusion Criteria: - 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 - Written informed consent Exclusion Criteria: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Poland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00801281 |
|---|---|
| Other Study ID Numbers | R-CVP/CHOP |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Polish Lymphoma Research Group |
| Study Sponsor | Polish Lymphoma Research Group |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jan A Walewski, Prof. Vice-president of PLRGStudy Chair: Maria Podolak-Dawidziak, Prof. PLRG Board MemberStudy Chair: Beata Stella-Hołowiecka, Assoc. Prof. PLRG Member |
| Verification Date | November 2011 |
Locations[ + expand ][ + ]
| Podkarpacki Oncology Centre | Brzozów, Poland, 36-200 |
|---|---|
| Voivodeship Hospital, Oncology Ward | Elbląg, Poland, 82-300 |
| Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology | Gdańsk, Poland, 80-211 |
| Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation | Katowice, Poland, 40-029 |
| Collegium Medicum Jagiellonian University, Clinic of Haematology | Kraków, Poland, 31-501 |
| Oncology Centre of Lublin Region | Lublin, Poland, 20-090 |
| M.Sklodowska-Curie Institute - Oncology Centre | Warszawa, Poland, 02-782 |
| Institute of Haematology and Transfusiology | Warszawa, Poland, 02-776 |
| Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases | Warszawa, Poland, 02-507 |
| SP ZOZ Silesian Centre of Cellular Transplantation | Wrocław, Poland, 53-439 |
| Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation | Wrocław, Poland, 50-367 |
| Regional Oncology Centre, Ward of Proliferative Diseases | Łódź, Poland, 93-509 |