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

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ClinicalTrials.gov Identifier: NCT00801281
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Polish Lymphoma Research Group

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Last Update Posted Date July 17, 2017
Study Start Date  ICMJE February 2007
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Event Free Survival [ Time Frame: +3 yrs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Response Rate [ Time Frame: +2 yrs ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
Official Title  ICMJE First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytic Lymphoma
Intervention  ICMJE
  • Drug: Rituximab
    Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
    Other Name: MabThera
  • Drug: Cyclophosphamide
    Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
    Other Name: Endoxan, Cytoxan
  • Drug: Doxorubicin
    Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
    Other Name: Adriamycin
  • Drug: Vincristine
    Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
    Other Name: Oncovin
  • Drug: Prednisone 1
    Prednisone 100 mg p.o. d. 1-5 q. 21 d.
    Other Name: Deltasone
  • Drug: Prednisone 2
    Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
    Other Name: Deltasone
Study Arms  ICMJE
  • Active Comparator: R-CVP
    Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Vincristine
    • Drug: Prednisone 2
  • Experimental: R-CHOP
    Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Vincristine
    • Drug: Prednisone 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2008)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2017
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801281
Other Study ID Numbers  ICMJE R-CVP/CHOP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Polish Lymphoma Research Group
Study Sponsor  ICMJE Polish Lymphoma Research Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Polish Lymphoma Research Group
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP