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

NCT00801281 | Completed Phase 3 DMC

• 1 other identifier: R-CVP/CHOP
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 12

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.

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%)

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  +3 yrs

Secondary Outcomes (1)

• Response Rate

  +2 yrs

Study Arms (2)

R-CVP

ACTIVE COMPARATOR

Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone 2

R-CHOP

EXPERIMENTAL

Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone 1

Interventions

Rituximab DRUG

Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.

Also known as: MabThera

R-CHOP; R-CVP

Cyclophosphamide DRUG

Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.

Also known as: Endoxan, Cytoxan

R-CHOP; R-CVP

Doxorubicin DRUG

Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.

Also known as: Adriamycin

R-CHOP

Vincristine DRUG

Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.

Also known as: Oncovin

R-CHOP; R-CVP

Prednisone 1 DRUG

Prednisone 100 mg p.o. d. 1-5 q. 21 d.

Also known as: Deltasone

R-CHOP

Prednisone 2 DRUG

Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Also known as: Deltasone

R-CVP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Lymphoma Research Group: lead

Study Sites (12)

Podkarpacki Oncology Centre

Brzozów, 36-200, Poland

Location

Voivodeship Hospital, Oncology Ward

Elblag, 82-300, Poland

Location

Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology

Gdansk, 80-211, Poland

Location

Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation

Katowice, 40-029, Poland

Location

Collegium Medicum Jagiellonian University, Clinic of Haematology

Krakow, 31-501, Poland

Location

Regional Oncology Centre, Ward of Proliferative Diseases

Lodz, 93-509, Poland

Location

Oncology Centre of Lublin Region

Lublin, 20-090, Poland

Location

Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases

Warsaw, 02-507, Poland

Location

Institute of Haematology and Transfusiology

Warsaw, 02-776, Poland

Location

M.Sklodowska-Curie Institute - Oncology Centre

Warsaw, 02-782, Poland

Location

Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation

Wroclaw, 50-367, Poland

Location

SP ZOZ Silesian Centre of Cellular Transplantation

Wroclaw, 53-439, Poland

Location

Related Links

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

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: February 1, 2007
• Primary Completion: June 25, 2017
• Study Completion: June 25, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (12)