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

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

Tracking Information

• First Submitted Date: December 2, 2008
• First Posted Date: December 3, 2008
• Last Update Posted Date: July 17, 2017
• Study Start Date: February 2007
• Actual Primary Completion Date: June 25, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2008): Event Free Survival [ Time Frame: +3 yrs ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 2, 2008): Response Rate [ Time Frame: +2 yrs ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Follicular Lymphoma
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma
• Lymphoplasmacytic Lymphoma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2008): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 25, 2017
• Actual Primary Completion Date: June 25, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT00801281
• Other Study ID Numbers: R-CVP/CHOP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Polish Lymphoma Research Group
• Study Sponsor: Polish Lymphoma Research Group
• Collaborators: Not Provided

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

• PRS Account: Polish Lymphoma Research Group
• Verification Date: July 2017