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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma

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Trial Information

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


Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months,
started 2 months after last chemotherapy.


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event Free Survival

Outcome Time Frame:

+3 yrs

Safety Issue:

Yes

Principal Investigator

Jan A Walewski, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vice-president of PLRG

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

R-CVP/CHOP

NCT ID:

NCT00801281

Start Date:

February 2007

Completion Date:

June 2012

Related Keywords:

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Lymphoma
  • Immunochemotherapy
  • Induction therapy
  • Maintenance therapy
  • Follicular lymphoma grade 1,2,3a
  • Marginal zone lymphoma, including MALT type
  • Small lymphocytic lymphoma (BM inv. <30%)
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell, Marginal Zone

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