NCT06355401

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
34mo left

Started Apr 2024

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2024Mar 2029

Study Start

First participant enrolled

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

Diffuse Large B Cell Lymphoma

Keywords

DLBCLmaintenance hormonal therapytamoxifenERB

Outcome Measures

Primary Outcomes (2)

  • disease free survival

    the period from CR till 1st relapse

    2-5 years

  • overall survival

    the period from 1st diagnosis till study end or death

    2-5 years

Secondary Outcomes (1)

  • side effects

    2-5 years

Study Arms (2)

group A

EXPERIMENTAL

DLBCL patients who achieve CR

Drug: Tamoxifen 20mg

group B

NO INTERVENTION

DLBCL patients who achieve CR will be under follow up only

Interventions

Tamoxifen 20mgDRUG

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

group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18-75 years old newly diagnosed DLBCL patients who achieve CR after conventional primary treatment can be included PS 0-2

You may not qualify if:

  • less than 18 years or older than 75 years other types of lymphoid neoplasms cardiac comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical oncology

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 9, 2024

Study Start

April 1, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2029

Last Updated

April 9, 2024

Record last verified: 2024-04