First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. (PLRG4)
This study is ongoing, but not recruiting participants.
Sponsor:
Polish Lymphoma Research Group
Information provided by (Responsible Party):
Polish Lymphoma Research Group
ClinicalTrials.gov Identifier:
NCT00801281
First received: December 2, 2008
Last updated: November 3, 2011
Last verified: November 2011
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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 | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma |
Drug: Rituximab, Cyclophosphamide, Vincristine, Prednisone Drug: Rituximab, Cyclophosphamid, Doxorubicin, Vincristine, Prednisone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Rituximab
U.S. FDA Resources
Further study details as provided by Polish Lymphoma Research Group:
Primary Outcome Measures:
- Event Free Survival [ Time Frame: +3 yrs ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response Rate [ Time Frame: +2 yrs ] [ Designated as safety issue: Yes ]
| Enrollment: | 250 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: R-CVP
Standard arm 1. - R-CVP
|
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.
|
|
Experimental: R-CHOP
Study arm 2. - R-CHOP
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 </=2
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801281
Locations
| Poland | |
| 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 | |
Sponsors and Collaborators
Polish Lymphoma Research Group
Investigators
| Principal Investigator: | Jan A Walewski, Prof. | Vice-president of PLRG |
| Study Chair: | Maria Podolak-Dawidziak, Prof. | PLRG Board Member |
| Study Chair: | Beata Stella-Hołowiecka, Assoc. Prof. | PLRG Member |
More Information
Additional Information:
No publications provided
| Responsible Party: | Polish Lymphoma Research Group |
| ClinicalTrials.gov Identifier: | NCT00801281 History of Changes |
| Other Study ID Numbers: | R-CVP/CHOP |
| Study First Received: | December 2, 2008 |
| Last Updated: | November 3, 2011 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Keywords provided by Polish Lymphoma Research Group:
|
Lymphoma Immunochemotherapy Induction therapy Maintenance therapy |
Follicular lymphoma grade 1,2,3a Marginal zone lymphoma, including MALT type Small lymphocytic lymphoma (BM inv. <30%) |
Additional relevant MeSH terms:
|
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Waldenstrom Macroglobulinemia Lymphoma, B-Cell, Marginal Zone Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoma, B-Cell Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013