Tamoxifen 20mg
Drugmaintenance TAM 20 mg daily for DLBCL who achieve CR after chemotherapy and/or radiotherapy and/or BMT
NCT Number: NCT06355401
the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
Diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma. The standard immuno-chemotherapy (R-CHOP) markedly improves the prognosis of DLBCL, but up to 40% of patients still experience relapse or incomplete remission . So, there is a need for new targeted therapy for such malignancy. Recent studies identified a potential novel target in DLBCL, the ESR2 gene, which codes for the estrogen receptor beta (ERβ) protein, a receptor that can be targeted with selective ER modulators (SERMs) such as tamoxifen. Recent data shows that exposure of DLBCL cell lines to tamoxifen (either alone or in combination with CHOP chemotherapy) results in apoptosis and growth inhibition in vitro and in vivo. these data suggest the potential importance of ERβ in the pathogenesis of DLBCL as well as a potential role for tamoxifen in the treatment of DLBCL.50-100 patients with newly diagnosed DLBCL will be treated with standard immuno-chemotherapy according to disease stage with detection of ERB and ERA on the tissue samples using IHC. After the end of chemotherapy treatment patients who achieve CR will be randomized to either receive tamoxifen maintenance (20 mg daily) versus follow up to evaluate possible tamoxifen effect on disease recurrence, DFS and OS.
PT who achieve CR after 2nd line chemotherapy versus post BMT will also be recruited.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
adults 18-75 years old newly diagnosed DLBCL patients who achieve CR after conventional primary treatment can be included PS 0-2
Exclusion criteria
less than 18 years or older than 75 years other types of lymphoid neoplasms cardiac comorbidity
maintenance TAM 20 mg daily for DLBCL who achieve CR after chemotherapy and/or radiotherapy and/or BMT
Time frame: 2-5 years
the period from CR till 1st relapse
Time frame: 2-5 years
the period from 1st diagnosis till study end or death
Time frame: 2-5 years
if there is any increase in adverse events while on TAM maintenance
Sohag University
Other
Effect of Maintenance Hormonal Therapy on the Outcome of Patients With DLBCL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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