Maintenance Hormonal Therapy and DLBCL

NCT ID: NCT06355401

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2029-03-31

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A

DLBCL patients who achieve CR

Group Type: EXPERIMENTAL

Tamoxifen 20mg

Intervention Type: DRUG

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

group B

DLBCL patients who achieve CR will be under follow up only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tamoxifen 20mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Gamal Mohamed Soliman

lecturer of clinical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Soh-Med-24-03--06PD

Identifier Type: -

Identifier Source: org_study_id