Maintenance Hormonal Therapy and DLBCL

Phase 2

Not yet recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Tamoxifen 20mg

• Registration Number: NCT06355401
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Tamoxifen 20mg	DLBCL patients who achieve CR

Primary Outcome Measures

Name	Time	Method
disease free survival	2-5 years	the period from CR till 1st relapse
overall survival	2-5 years	the period from 1st diagnosis till study end or death

Secondary Outcome Measures

Name	Time	Method
side effects	2-5 years	if there is any increase in adverse events while on TAM maintenance