|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Polish Lymphoma Research Group |
|---|---|
| Information provided by: | Polish Lymphoma Research Group |
| ClinicalTrials.gov Identifier: | NCT00801281 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
R-CVP: Active Comparator
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.
|
|
R-CHOP: Experimental
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jan A Walewski, Prof. | 0048 22 546 2223 | walewski@coi.waw.pl |
| Poland | |
| M.Sklodowska-Curie Institute - Oncology Centre | Recruiting |
| Warszawa, Poland, 02-782 | |
| Principal Investigator: Jan A Walewski, Prof. | |
| Sub-Investigator: Joanna Romejko-Jarosińska, MD., PhD | |
| Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation | Recruiting |
| Katowice, Poland, 40-029 | |
| Principal Investigator: Jerzy Holowiecki, Prof. | |
| Collegium Medicum Jagiellonian University, Clinic of Haematology | Recruiting |
| Kraków, Poland, 31-501 | |
| Principal Investigator: Aleksander Skotnicki, Prof. | |
| Institute of Haematology and Transfusiology | Recruiting |
| Warszawa, Poland, 02-776 | |
| Principal Investigator: Krzysztof Warzocha, Prof. | |
| Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases | Recruiting |
| Warszawa, Poland, 02-507 | |
| Principal Investigator: Andrzej Deptała, Assoc. Prof. | |
| SP ZOZ Silesian Centre of Cellular Transplantation | Recruiting |
| Wrocław, Poland, 53-439 | |
| Principal Investigator: Andrzej Lange, Prof. | |
| Voivodeship Hospital, Oncology Ward | Active, not recruiting |
| Elbląg, Poland, 82-300 | |
| Regional Oncology Centre, Ward of Proliferative Diseases | Recruiting |
| Łódź, Poland, 93-509 | |
| Principal Investigator: Ewa Kalinka-Warzocha, MD, PhD | |
| Voivodeship Podkarpacki Hospital | Recruiting |
| Krosno, Poland, 38-400 | |
| Principal Investigator: Waldemar Hołda, MD, PhD | |
| Sub-Investigator: Andrzej Paprocki, MD, PhD | |
| Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology | Active, not recruiting |
| Gdańsk, Poland, 80-211 | |
| Oncology Centre of Lublin Region | Active, not recruiting |
| Lublin, Poland, 20-090 | |
| Health Care Centre Mrukmed Sp. p. | Active, not recruiting |
| Rzeszów, Poland, 35-242 | |
| Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation | Recruiting |
| Wrocław, Poland, 50-367 | |
| Principal Investigator: Kazimierz Kuliczkowski, Prof. | |
| Sub-Investigator: Maria Podolak-Dawidziak, Prof. | |
| 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
| Responsible Party: | Polish Lymphoma Research Group ( Prof. Jan Walewski, MD, PhD ) |
| Study ID Numbers: | R-CVP/CHOP |
| Study First Received: | December 2, 2008 |
| Last Updated: | December 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00801281 History of Changes |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
|
Lymphoma Immunochemotherapy Induction therapy Maintenance therapy |
Follicular lymphoma grade 1,2,3a Marginal zone lymphoma, including MALT type Small lymphocytic lymphoma (BM inv. <30%) |
|
Anti-Inflammatory Agents Prednisone Leukemia, Lymphoid Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Follicular Lymphoma Anti-Bacterial Agents Leukemia |
Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Alkylating Agents Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents |
|
Anti-Inflammatory Agents Prednisone Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Paraproteinemias Cyclophosphamide Antibiotics, Antineoplastic Hemostatic Disorders Hormones |
Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Rituximab Mitosis Modulators Vascular Diseases |
