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NCT02428751
Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study
Phase 3 trial testing Pegylated liposomal doxorubicin in Lymphoma, Large B-Cell, Diffuse in 216 participants. Status unknown.
1 March 2020
Quick facts
| Lead sponsor | Wenqi Jiang |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 216 |
| Start date | 1 September 2015 |
| Primary completion | 1 March 2020 |
| Estimated completion | 1 May 2020 |
| Sites | 7 locations across China |
Drugs / interventions tested
- Pegylated liposomal doxorubicin
- Doxorubicin
- Rituximab — full drug profile →
- Cyclophophamide — full drug profile →
- Vincristine (vincristine) — full drug profile →
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Lymphoma, Large B-Cell, Diffuse — all drugs for Lymphoma, Large B-Cell, Diffuse →
Sponsor
Wenqi Jiang — full company profile →
Who can join
Adults 60 to 80, any sex, with Lymphoma, Large B-Cell, Diffuse. 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.
-
event-free survival (EFS)
Time frame: two year
Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up
Sponsor's own description
The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02428751
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other recruiting trials for Lymphoma, Large B-Cell, Diffuse
Currently open trials in the same condition.
- NCT06890884 — A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R- · Phase 2 · recruiting
- NCT06254495 — A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers · Phase 1 · active not recruiting
- NCT06093841 — Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL · Phase 2 · active not recruiting
- NCT05800366 — A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma · Phase 2 · recruiting
- NCT05798156 — Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell · Phase 2 · active not 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 NCT02428751 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wenqi Jiang
- Last refreshed: 17 November 2015
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/NCT02428751.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing