R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients

Study Overview
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Brief Summary
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Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients

Detailed Description
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Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)

Official Title
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Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Treatment plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma Age 18-80 years (patients >70 years old: FIT according to VGM evaluation). aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm) ECOG-PS < 3 unless due to lymphoma Ventricular ejection fraction ≥ 50% Pulmonary, renal and hepatic tests within normal range Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml. Written informed consent Life-expectancy > 3 months Main Exclusion Criteria: T-cell lymphoma Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma PS> 3 (if not due to lymphoma) Age-adjusted IPI = 0 in the absence of bulky disease Age> 80 and <18 years (see inclusion criteria) HIV positivity significant cardiopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm for all patients<br>Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21. | Drug: Treatment plan<br>* R-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS Progression Free Survival | defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS Overall Survival | OS will be defined as the time between the date of initiation of therapy and the date of death from any cause or the date of last follow up | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBCL