Clinical trial · Interventional
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone 1 | Drug | Prednisone | ALIAS |
| Prednisone 2 | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- R-CVP
- description
- Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone 2
- type
- EXPERIMENTAL
- label
- R-CHOP
- description
- Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone 1
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available