Clinical trial NCT00801281: First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Marginal Zone Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytic Lymphoma
Keywords: Lymphoma
Immunochemotherapy
Induction therapy
Maintenance therapy
Follicular lymphoma grade 1,2,3a
Marginal zone lymphoma, including MALT type
Small lymphocytic lymphoma (BM inv. <30%)
Lead sponsor: Polish Lymphoma Research Group
Sponsor class: NETWORK
First posted: 2008-12-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Event Free Survival
timeFrame: +3 yrs
Secondary outcomes:
measure: Response Rate
timeFrame: +2 yrs
Other outcomes:
Locations:
city: Brzozów
country: Poland
facility: Podkarpacki Oncology Centre
city: Elbląg
country: Poland
facility: Voivodeship Hospital, Oncology Ward
city: Gdańsk
country: Poland
facility: Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
city: Katowice
country: Poland
facility: Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
city: Kraków
country: Poland
facility: Collegium Medicum Jagiellonian University, Clinic of Haematology
city: Lublin
country: Poland
facility: Oncology Centre of Lublin Region
city: Warszawa
country: Poland
facility: Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
city: Warszawa
country: Poland
facility: Institute of Haematology and Transfusiology
city: Warszawa
country: Poland
facility: M.Sklodowska-Curie Institute - Oncology Centre
city: Wrocław
country: Poland
facility: Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation
city: Wrocław
country: Poland
facility: SP ZOZ Silesian Centre of Cellular Transplantation
city: Łódź
country: Poland
facility: Regional Oncology Centre, Ward of Proliferative Diseases
Study officials:
affiliation: Vice-president of PLRG
name: Jan A Walewski, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: PLRG Board Member
name: Maria Podolak-Dawidziak, Prof.
role: STUDY_CHAIR
affiliation: PLRG Member
name: Beata Stella-Hołowiecka, Assoc. Prof.
role: STUDY_CHAIR
References: