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Trial Title:
Maintenance Hormonal Therapy and DLBCL
NCT ID:
NCT06355401
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Tamoxifen
Conditions: Keywords:
DLBCL
maintenance hormonal therapy
tamoxifen
ERB
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Tamoxifen 20mg
Description:
maintenance TAM 20 mg daily for DLBCL who achieve CR after chemotherapy and/or
radiotherapy and/or BMT
Arm group label:
group A
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355401
