search
Back to results

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

Primary Purpose

Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone 1
Prednisone 2
Sponsored by
Polish Lymphoma Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Lymphoma, Immunochemotherapy, Induction therapy, Maintenance therapy, Follicular lymphoma grade 1,2,3a, Marginal zone lymphoma, including MALT type, Small lymphocytic lymphoma (BM inv. <30%)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Podkarpacki Oncology Centre
  • Voivodeship Hospital, Oncology Ward
  • Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
  • Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
  • Collegium Medicum Jagiellonian University, Clinic of Haematology
  • Oncology Centre of Lublin Region
  • Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
  • Institute of Haematology and Transfusiology
  • M.Sklodowska-Curie Institute - Oncology Centre
  • Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation
  • SP ZOZ Silesian Centre of Cellular Transplantation
  • Regional Oncology Centre, Ward of Proliferative Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

R-CVP

R-CHOP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Event Free Survival

Secondary Outcome Measures

Response Rate

Full Information

First Posted
December 2, 2008
Last Updated
July 12, 2017
Sponsor
Polish Lymphoma Research Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00801281
Brief Title
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 25, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polish Lymphoma Research Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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%)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CVP
Arm Type
Active Comparator
Arm Description
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
Arm Title
R-CHOP
Arm Type
Experimental
Arm Description
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera
Intervention Description
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan, Cytoxan
Intervention Description
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Intervention Type
Drug
Intervention Name(s)
Prednisone 1
Other Intervention Name(s)
Deltasone
Intervention Description
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Intervention Type
Drug
Intervention Name(s)
Prednisone 2
Other Intervention Name(s)
Deltasone
Intervention Description
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Primary Outcome Measure Information:
Title
Event Free Survival
Time Frame
+3 yrs
Secondary Outcome Measure Information:
Title
Response Rate
Time Frame
+2 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Walewski, Prof.
Organizational Affiliation
Vice-president of PLRG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Podolak-Dawidziak, Prof.
Organizational Affiliation
PLRG Board Member
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Beata Stella-Hołowiecka, Assoc. Prof.
Organizational Affiliation
PLRG Member
Official's Role
Study Chair
Facility Information:
Facility Name
Podkarpacki Oncology Centre
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Voivodeship Hospital, Oncology Ward
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
City
Katowice
ZIP/Postal Code
40-029
Country
Poland
Facility Name
Collegium Medicum Jagiellonian University, Clinic of Haematology
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Oncology Centre of Lublin Region
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Institute of Haematology and Transfusiology
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
M.Sklodowska-Curie Institute - Oncology Centre
City
Warszawa
ZIP/Postal Code
02-782
Country
Poland
Facility Name
Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
SP ZOZ Silesian Centre of Cellular Transplantation
City
Wrocław
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Regional Oncology Centre, Ward of Proliferative Diseases
City
Łódź
ZIP/Postal Code
93-509
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.plrg.coi.pl
Description
Click here to provide more information about this study: PLRG4

Learn more about this trial

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

We'll reach out to this number within 24 hrs