First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.

Follicular Lymphoma Clinical Trial

— PLRG4  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801281
• Other study ID #: R-CVP/CHOP
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2008
• Last updated: July 12, 2017
• Start date: February 2007
• Est. completion date: June 25, 2017

Study information

• Verified date: July 2017
• Source: Polish Lymphoma Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 25, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoplasmacytic Lymphoma
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
• Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
• Doxorubicin
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
• Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
• Prednisone 1
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
• Prednisone 2
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Locations

Country	Name	City	State
Poland	Podkarpacki Oncology Centre	Brzozów
Poland	Voivodeship Hospital, Oncology Ward	Elblag
Poland	Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology	Gdansk
Poland	Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation	Katowice
Poland	Collegium Medicum Jagiellonian University, Clinic of Haematology	Kraków
Poland	Regional Oncology Centre, Ward of Proliferative Diseases	Lódz
Poland	Oncology Centre of Lublin Region	Lublin
Poland	Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases	Warszawa
Poland	Institute of Haematology and Transfusiology	Warszawa
Poland	M.Sklodowska-Curie Institute - Oncology Centre	Warszawa
Poland	Medical Academy in Wroclaw; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation	Wroclaw
Poland	SP ZOZ Silesian Centre of Cellular Transplantation	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Polish Lymphoma Research Group

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival		+3 yrs
Secondary	Response Rate		+2 yrs

External Links

•   Click here to provide more information about this study: PLRG4