First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. (PLRG4)

July 12, 2017 updated by: Polish Lymphoma Research Group

First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Brzozów, Poland, 36-200
        • Podkarpacki Oncology Centre
      • Elbląg, Poland, 82-300
        • Voivodeship Hospital, Oncology Ward
      • Gdańsk, Poland, 80-211
        • Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
      • Katowice, Poland, 40-029
        • Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
      • Kraków, Poland, 31-501
        • Collegium Medicum Jagiellonian University, Clinic of Haematology
      • Lublin, Poland, 20-090
        • Oncology Centre of Lublin Region
      • Warszawa, Poland, 02-507
        • Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
      • Warszawa, Poland, 02-776
        • Institute of Haematology and Transfusiology
      • Warszawa, Poland, 02-782
        • M.Sklodowska-Curie Institute - Oncology Centre
      • Wrocław, Poland, 50-367
        • Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation
      • Wrocław, Poland, 53-439
        • SP ZOZ Silesian Centre of Cellular Transplantation
      • Łódź, Poland, 93-509
        • Regional Oncology Centre, Ward of Proliferative Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
Drug: Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Other Names:
  • MabThera
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Other Names:
  • Endoxan, Cytoxan
Drug: Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Other Names:
  • Oncovin
Drug: Prednisone 2
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Other Names:
  • Deltasone
EXPERIMENTAL: R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
Drug: Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Other Names:
  • MabThera
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Other Names:
  • Endoxan, Cytoxan
Drug: Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Other Names:
  • Oncovin
Drug: Doxorubicin
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Other Names:
  • Adriamycin
Drug: Prednisone 1
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Other Names:
  • Deltasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival
Time Frame: +3 yrs
+3 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: +2 yrs
+2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

June 25, 2017

Study Completion (ACTUAL)

June 25, 2017

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 3, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-CVP/CHOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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