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NCT03943901
A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma
Phase 2 trial testing Rituximab in Diffuse Large B Cell Lymphoma in 27 participants. Participants enrolled and being followed up; not accepting new ones.
13 January 2025
Quick facts
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 17 February 2021 |
| Primary completion | 13 January 2025 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rituximab — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Doxorubicin
- Vincristine (vincristine) — full drug profile →
- Prednisone (prednisone) — full drug profile →
- Pegfilgrastim (PEGFILGRASTIM) — full drug profile →
Conditions studied
- Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
- DLBCL — all drugs for DLBCL →
- Cancer — all drugs for Cancer →
Sponsor
University of Wisconsin, Madison
Who can join
70 and older, any sex, with Diffuse Large B Cell Lymphoma or DLBCL. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Complete Response Rate (CR)
Time frame: up to 6 months
Simon 2-stage design with complete response (CR) rate at the end of treatment as our primary outcome. 40% is an unacceptable boundary for complete response rate and 60% as an acceptable complete response rate. CR at the end of treatment, will be estimated as the observed proportion and presented with a 95% Wilson confidence interval.
Sponsor's own description
This study is investigating a new administration schedule of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) chemotherapy for participants with Diffuse Large B-Cell Lymphoma (DLBCL), focusing on an underserved elderly population (aged 75 and up; certain participants 70-74 may be eligible) that is often excluded from clinical trials. Participants can expect to be on study for 2.5 years (treatment for 6 months and 2 years of post treatment follow-up).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Geriatric assessment in older adults with non-Hodgkin lymphoma: A Young International Society of Geriatric Oncology (YSIOG) review paper.
Akhtar OS, Huang LW, Tsang M, Torka P, et al · · 2022 · cited 18× · PMID 35216939 · DOI 10.1016/j.jgo.2022.02.005 -
Diffuse Large B-Cell Lymphoma in the Older and Frail Patient.
Ayers EC, Smith SM. · · 2025 · PMID 40075732 · DOI 10.3390/cancers17050885
Verify or expand the search:
- PubMed search for NCT03943901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rituximab
Trials testing the same drug.
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- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
- NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia · Phase 1, PHASE2 · recruiting
- NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
Other recruiting trials for Diffuse Large B Cell Lymphoma
Currently open trials in the same condition.
- NCT06687772 — CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant · Phase 2 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06736613 — A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma · Phase 2 · recruiting
- NCT06552572 — Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy · Phase 2 · active not recruiting
- NCT06550141 — Emapalumab Prevention of CAR-T Cell Associated Toxicities · Phase 2 · recruiting
Other University of Wisconsin, Madison trials
Trials by the same sponsor.
- NCT07440004 — Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts · Phase 1 · recruiting
- NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
- NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
- NCT07470723 — The ORIGIN-FH Study · NA · recruiting
- NCT06975657 — Well-being Skills for Reentry · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03943901 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
- Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03943901.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing