PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.
A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with DLBCL limited stages and without risk factors 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. |
Other: Evaluation of first line treatment in patients with stage I and II LBCL
Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
|
Outcome Measures
Primary Outcome Measures
- 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. [36 months]
- Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP [36 months]
Secondary Outcome Measures
- Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP. [36 months]
- Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy. [36 months]
- Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP [36 months]
- Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP [36 months]
- Evaluate the prognostic value of Δ SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP [36 months]
- Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6 [36 months]
- Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP) [36 months]
- Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin [36 months]
- Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin [36 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients > 17 years old with no upper age limit.
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Histological diagnosis of DLBCL Stages I or II
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Patients who have signed informed consent.
Exclusion Criteria:
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Patients with elevated LDH (lactate dehydrogenase)
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ECOG (Eastern Cooperative Oncology Group) > 2
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Stage III or IV
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Bulky mass (> 7.5 cm)
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Central nervous system involvement
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Testicular lymphoma
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Breast involvement
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Eyeball involvement
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Primary mediastinal lymphoma
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Cutaneous primary lymphoma
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Diffuse large B-cell lymphoma of the leg
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HIV positive patients
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Platelet count <100,000 / mcl and total leukocyte count <3,000 / mcl
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Marked impairment of ventricular function (FEy <50%)
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Moderate / severe renal impairment defined by Cl. Cr. <50 ml / min
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Severe liver disease: prothrombin rate <50% and / or bile level. total> 2.5 times normal value
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Pregnant and breastfeeding
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Previous or concomitant diagnosis of indolent lymphoma
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Patients who have previously received chemotherapy and / or radiotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IDHEA Clinica Hematologica | Rosario | Santa Fe | Argentina | |
| 2 | FUNDALEU | Caba | Argentina |
Sponsors and Collaborators
- Grupo Argentino de Tratamiento de la Leucemia Aguda
Investigators
- Principal Investigator: Amalia Cerutti, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda
- Study Chair: Astrid Pavlovsky, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GATLA 10-LNHDCG-20