At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed aggressive B-cell non-Hodgkin lymphoma (includes DLBCL, Burkitt, mantle cell blastoid, primary mediastinal, grade 3 follicular, and other specified subtypes)
- ✓Previously untreated disease (no prior chemotherapy or radiotherapy)
- ✓CD20-positive disease
- ✓International Prognostic Index (IPI) score 0 or 1 (age-adjusted); IPI 0 allowed only if bulky disease (largest tumor ≥7.5 cm)
- ✕MALT lymphoma
- ✕CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
- ✕Known HIV-positivity
- ✕Active hepatitis infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI=1 (All) or IPI=0 With a Large Tumour Mass (≥7.5 cm) [UNFOLDER 21/14 Study]
In Brief
A Phase 3 clinical trial evaluating filgrastim, rituximab, and 5 other interventions for Lymphoma. Completed, enrolled 700 participants across 152 sites in 4 countries.
Detailed 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.