Clinical trial · Observational
Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
Observational, Post-authorization, Cross-sectional Study to Evaluate the Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
NCT01369784CI-TRIAL-00021791PRO-R-IPIcompletedResults postedClinicalTrials.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)
The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.
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
- refractory/relapsed LDCBG
- description
- patients with refractory/relapsed diffuse large B-cell lymphoma
Primary outcomes (3)
- measure
- R-IPI Index (Revised International Prognostic Index)
- timeFrame
- At diagnoses
- description
- Data will be recorded from diagnosis to second line response, an expected average of 7 months
- measure
- R-IPI Index (Revised International Prognostic Index)
- timeFrame
- At the beginning of the 2nd line of treatment, an average of 2 years
- description
- The IPI is based on the evaluation of 5 clinical factors: age \> 60 years Ann Arbor stage III or IV disease \> 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) \_ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Age 18 \> years old * Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab * Ability to understand and willingness to sign a written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.