Clinical trial · Interventional
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
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]
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Interventional: 6 R-CHOP-21
- description
- Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- type
- ACTIVE_COMPARATOR
- label
- Interventional: 6 R-CHOP-21 + radiotherapy
- description
- Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 studiesReferences
Publications (3)
- RESULTRadiotherapy (RT) to bulky (B) and extralymphatic (E) disease in combination with 6xR-CHOP-14 or R-CHOP-21 in young good-prognosis DLBCL patients: Results of the 2x2 randomized UNFOLDER trial of the DSHNHL/GLA. Michael Pfreundschuh, Niels Murawski, Marita Ziepert, Bettina Altmann, Martin H. Dreyling, Peter Borchmann, Stefano Luminari, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Lorenz Truemper, Bernd Metzner, Eva Lengfelder, Ulrich B. Keller, Christian Ruebe, Christian Berdel, Norbert Schmitz, Gerhard Held, and Viola Poeschel Journal of Clinical Oncology 2018 36:15_suppl, 7574-7574
- RESULTRole of radiotherapy and dose-densification of R-CHOP in primary mediastinal B-cell lymphoma: A subgroup analysis of the unfolder trial of the German Lymphoma Alliance (GLA). Gerhard Held, Lorenz Thurner, Viola Poeschel, Christian Berdel, German Ott, Christian Schmidt, Andreas Viardot, Peter Borchmann, Ofer Shpilberg, Maike Nickelsen, Massimo Federico, Peter de Nully Brown, Niels Murawski, Lorenz H. Trumper, Heinz Schmidberger, Christian Ruebe, Jochen Fleckenstein, Norbert Schmitz, Markus Loeffler, Marita Ziepert, and German Lymphoma Alliance Journal of Clinical Oncology 2020 38:15_suppl, 8041-8041
- DERIVEDThurner L, Ziepert M, Berdel C, Schmidt C, Borchmann P, Kaddu-Mulindwa D, Viardot A, Witzens-Harig M, Dierlamm J, Haenel M, Metzner B, Wulf G, Lengfelder E, Keller UB, Frickhofen N, Nickelsen M, Gaska T, Griesinger F, Mahlberg R, Marks R, Shpilberg O, Lindemann HW, Soekler M, Fischer von Weikersthal L, Kiehl M, Roemer E, Bentz M, Krammer-Steiner B, Trappe R, de Nully Brown P, Federico M, Merli F, Engelhard M, Glass B, Schmitz N, Truemper L, Bewarder M, Hartmann F, Murawski N, Stilgenbauer S, Rosenwald A, Altmann B, Schmidberger H, Fleckenstein J, Loeffler M, Poeschel V, Held G. Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study. Hemasphere. 2023 Jul 5;7(7):e904. doi: 10.1097/HS9.0000000000000904. eCollection 2023 Jul. PMID 37427146