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NCT Number: NCT06355401

Maintenance Hormonal Therapy and DLBCL

the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL

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Key information

About this study

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.

Who can participate

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

Treatment and study plan

Tamoxifen 20mg

Drug

maintenance TAM 20 mg daily for DLBCL who achieve CR after chemotherapy and/or radiotherapy and/or BMT

Primary outcomes

  1. disease free survival

    Time frame: 2-5 years

    the period from CR till 1st relapse

  2. overall survival

    Time frame: 2-5 years

    the period from 1st diagnosis till study end or death

Secondary outcomes

  1. side effects

    Time frame: 2-5 years

    if there is any increase in adverse events while on TAM maintenance

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Effect of Maintenance Hormonal Therapy on the Outcome of Patients With DLBCL

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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