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:
Information provided by (Responsible Party):
Polish Lymphoma Research Group
ClinicalTrials.gov Identifier:
NCT00801281
First received: December 2, 2008
Last updated: January 27, 2014
Last verified: November 2011
  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:


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 2017
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 27, 2014
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:
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Rituximab
Liposomal doxorubicin
Cyclophosphamide
Vincristine
Doxorubicin
Prednisone

ClinicalTrials.gov processed this record on September 30, 2014