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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.
Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CVP | Active Comparator | Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2 |
|
| R-CHOP | Experimental | Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 375 mg/m2 i.v. d. 1 q. 21 d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival | +3 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | +2 yrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan A Walewski, Prof. | Vice-president of PLRG | Principal Investigator |
| Maria Podolak-Dawidziak, Prof. | PLRG Board Member | Study Chair |
| Beata Stella-Hołowiecka, Assoc. Prof. | PLRG Member | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podkarpacki Oncology Centre | Brzozów | 36-200 | Poland | |||
| Voivodeship Hospital, Oncology Ward |
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| Label | URL |
|---|---|
| Click here to provide more information about this study: PLRG4 | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2022 | |
| Reset | Jul 21, 2022 |
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| Cyclophosphamide | Drug | Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d. |
|
|
| Doxorubicin | Drug | Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d. |
|
|
| Vincristine | Drug | Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d. |
|
|
| Prednisone 1 | Drug | Prednisone 100 mg p.o. d. 1-5 q. 21 d. |
|
|
| Prednisone 2 | Drug | Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d. |
|
|
| Elblag |
| 82-300 |
| Poland |
| Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology | Gdansk | 80-211 | Poland |
| Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation | Katowice | 40-029 | Poland |
| Collegium Medicum Jagiellonian University, Clinic of Haematology | Krakow | 31-501 | Poland |
| Regional Oncology Centre, Ward of Proliferative Diseases | Lodz | 93-509 | Poland |
| Oncology Centre of Lublin Region | Lublin | 20-090 | Poland |
| Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases | Warsaw | 02-507 | Poland |
| Institute of Haematology and Transfusiology | Warsaw | 02-776 | Poland |
| M.Sklodowska-Curie Institute - Oncology Centre | Warsaw | 02-782 | Poland |
| Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation | Wroclaw | 50-367 | Poland |
| SP ZOZ Silesian Centre of Cellular Transplantation | Wroclaw | 53-439 | Poland |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2022 | Jul 21, 2022 |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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