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

Yan Zhang, MD

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT06176729

2022-PUMCH-A-194

Details and patient eligibility

About

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).

Full description

In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.

The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.

Enrollment: 30 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental arm

Experimental group

Description:

Pola-R2 regimen Drug: Polatuzumab 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

Treatment:

Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide