Clinical trial · Observational
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL
NCT01340443CI-TRIAL-00030352completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.
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 |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Safety: Incidence of adverse events
- timeFrame
- 4.5 years
Secondary outcomes (3)
- measure
- Overall Response Rate (complete response + partial response)
- timeFrame
- 4.5 years
- measure
- Progression-free survival, defined as time from first treatment to lymphoma progression or death
- timeFrame
- 4.5 years
- measure
- Overall Survival, defined as time from 1st treatment to death of any cause
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma * Treatment with MabThera/Rituxan as per locally approved China package insert * Documented patient with medical records Exclusion Criteria: * Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
References
Publications (2)
- DERIVEDWu JQ, Song YP, Su LP, Zhang MZ, Li W, Hu Y, Zhang XH, Gao YH, Niu ZX, Feng R, Wang W, Peng JW, Li XL, Ouyang XN, Wu CP, Zhang WJ, Zeng Y, Xiao Z, Liang YM, Zhuang YZ, Wang JS, Sun ZM, Bai H, Cui TJ, Feng JF. Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study. Chin Med J (Engl). 2018 Aug 5;131(15):1767-1775. doi: 10.4103/0366-6999.237401. PMID 30058572
- DERIVEDWu J, Song Y, Su L, Xu L, Chen T, Zhao Z, Zhang M, Li W, Hu Y, Zhang X, Gao Y, Niu Z, Feng R, Wang W, Peng J, Li X, Ouyang X, Wu C, Zhang W, Zeng Y, Xiao Z, Liang Y, Zhuang Y, Wang J, Sun Z, Bai H, Cui T, Feng J. Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study. BMC Cancer. 2016 Jul 26;16:537. doi: 10.1186/s12885-016-2523-7. PMID 27460571