Completed PHASE3 INTERVENTIONAL 4-arm NCT00278408

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]

Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group

Conditions Lymphoma

Interventions cyclophosphamide doxorubicin hydrochloride filgrastim prednisone radiation therapy rituximab vincristine sulfate

Updated 9 times since 2017 Last updated: Aug 7, 2025 Started: Jan 2, 2006 Primary completion: Feb 28, 2018 Completion: Feb 28, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00278408, this PHASE3 trial focuses on Lymphoma and remains completed. Sponsored by German High-Grade Non-Hodgkin's Lymphoma Study Group, it has been updated 9 times since 2006, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Apr 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Apr 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

May 2019 — Jan 2021 [monthly]

Completed PHASE3
Apr 2019 — May 2019 [monthly]

Completed PHASE3
Jun 2018 — Apr 2019 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Jan 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

German High-Grade Non-Hodgkin's Lymphoma Study Group

Data source: Universität des Saarlandes

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Amberg, Germany , Augsburg, Germany , Aurich, Germany , Bayreuth, Germany , Berlin, Germany , Bielefeld, Germany , Bochum, Germany , Bonn, Germany , Braunschweig, Germany and 107 more locations