Phase 3
Completed N=695
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00278408 ↗Enrolled (actual)
695
Serious AEs
25.2%
Results posted
Aug 2025
Primary outcomePrimary: 3 Years Event-free Survival — 51; 56; 126; 123 Participants
◆ Published Evidence
Emerging
16citations · ~5 / year
Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study.
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
Linked Publications
-
Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Years Event-free Survival |
51; 56; 126; 123; 89; 92 | — |
| SECONDARY 3 Years Progression-free Survival |
64; 68; 133; 136; 96; 104 | — |
| SECONDARY 3 Years Overall Survival |
76; 74; 144; 141; 107; 108 | — |
| SECONDARY Rate of Complete Remissions and Progressive Disease |
64; 64; 141; 133; 109; 105 | — |
| SECONDARY Number of Patients With a Relapse After a CR/CRu |
12; 8; 13; 9; 18; 7 | — |
| SECONDARY Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) |
4; 1; 7; 4; 8; 8 | — |
| SECONDARY Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median) |
12; 12; 12; 12; 12; 12 | — |
| SECONDARY Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion |
21; 25; 42; 39; 22; 36 | — |
| SECONDARY Adherence to Protocol - Total Duration of Chemotherapy in Days (Median) |
105; 70; 105; 71; 105; 70 | — |
| SECONDARY Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) |
4474; 4482; 4464; 4474; 4476; 4455 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
- Grade 3 follicular lymphoma
- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
- Centroblastic
- Immunoblastic
- Plasmablastic
- Anaplastic large cell
- T-cell-rich B-cell lymphoma
- Primary effusion lymphoma
- Intravascular B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Burkitt's or Burkitt-like lymphoma
- Mantle cell lymphoma (blastoid)
- Aggressive marginal zone lymphoma (monocytoid)
- Previously untreated disease
- CD20-positive disease
- International prognostic index (IPI) score 0 or 1 (age-adjusted)
- Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
- No mucosa-associated lymphoid tissue (MALT) lymphoma
- No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Platelet count ≥ 100,000/mm³
- WBC ≥ 2,500/mm³
- No known hypersensitivity to the study medications
- No known HIV-positivity
- No active hepatitis infection
- Not pregnant or lactating
- Negative pregnancy test
- No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
- No impaired left ventricular function
- No severe cardiac arrhythmias
- No other impaired organ function
- No other serious disorder
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No prior immunosuppressive treatment with cytostatics
- No concurrent participation in other treatment studies
Data sourced from ClinicalTrials.gov (NCT00278408) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.