NCT00101010: Liposomal doxorubicin for diffuse large B-cell lymphoma

NCT00101010 was a single-arm phase II study replacing conventional doxorubicin with pegylated liposomal doxorubicin in an R-CHOP-like regimen for older patients with diffuse large B-cell lymphoma. The publication reports 80 toxicity-evaluable patients and 79 eligible patients in the efficacy analysis, with a median age of 69. 1 2

The overall response rate was 86%, with 78% complete responses. Estimated five-year event-free and overall survival were 52% and 70%, respectively. Cardiac toxicity was not eliminated: three patients, 4%, had grade 3 or worse cardiac events, and one death was attributed to cardiac failure; additional lower-grade cardiac events occurred. 2

These results support activity of the investigated regimen but do not prove better survival or lower cardiac risk than standard R-CHOP, because there was no randomized standard-regimen comparison. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00101010. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00101010. Original study registration: sponsor, design, population, endpoints and dated history.

2. Original full-text phase II report — Original full-text phase II reportCited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.