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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 December 2021 |
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Main ID: |
NCT03364439 |
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Date of registration:
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01/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
FIL_DLCL10 |
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Scientific 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) |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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112 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03364439 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Maria Giuseppina Cabras |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ospedale Businco di Cagliari |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Large B Cell Lymphoma
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Intervention(s)
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Drug: Treatment plan
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Primary Outcome(s)
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PFS Progression Free Survival
[Time Frame: 24 months]
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Secondary Outcome(s)
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OS Overall Survival
[Time Frame: 48 months]
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Secondary ID(s)
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FIL_DLCL10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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