Clinical trial · Observational
PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)
NCT05078840CI-TRIAL-00072831unknownClinicalTrials.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)
Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.
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 |
|---|---|---|---|
| Lymphoma, Non-Hodgkin's, Adult | Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of first line treatment in patients with stage I and II LBCL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with DLBCL limited stages and without risk factors
- description
- Patients with DLBCL in limited stages and without risk factors that will receive standard chemoimmunotherapy and their treatment will be adapted according to PET response after 3 cycles.
- interventionNames
- Other: Evaluation of first line treatment in patients with stage I and II LBCL
Primary outcomes (2)
- measure
- Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP.
- timeFrame
- 36 months
- measure
- Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
- timeFrame
- 36 months
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 17 years old with no upper age limit. * Histological diagnosis of DLBCL Stages I or II * Patients who have signed informed consent. Exclusion Criteria: * Patients with elevated LDH (lactate dehydrogenase) * ECOG (Eastern Cooperative Oncology Group) \> 2 * Stage III or IV * Bulky mass (\> 7.5 cm) * Central nervous system involvement * Testicular lymphoma * Breast involvement * Eyeball involvement * Primary mediastinal lymphoma * Cutaneous primary lymphoma * Diffuse large B-cell lymphoma of the leg * HIV positive patients * Platelet count \<100,000 / mcl and total leukocyte count \<3,000 / mcl * Marked impairment of ventricular function (FEy \<50%) * Moderate / severe renal impairment defined by Cl. Cr. \<50 ml / min * Severe liver disease: prothrombin rate \<50% and / or bile level. total\> 2.5 times normal value * Pregnant and breastfeeding * Previous or concomitant diagnosis of indolent lymphoma * Patients who have previously received chemotherapy and / or radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.