RecruitingPhase 2NCT06176729

Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients

A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients


Sponsor

Yan Zhang, MD

Enrollment

30 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).


Eligibility

Min Age: 70 Years

Inclusion Criteria4

  • The patient volunteered to participate in the study and signed the Informed Consent
  • Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
  • Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
  • Adequate organ function and adequate bone marrow reserve

Exclusion Criteria3

  • Coexisting malignancy other than lymphoma
  • Active HBV infection
  • Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy

Interventions

DRUGPolatuzumab Vedotin, Rituximab, Lenalidomide

polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06176729


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