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

NCT ID: NCT06176729

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-24
• Study Completion Date: 2027-10-24

Brief 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).

Detailed 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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

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

Group Type: EXPERIMENTAL

Polatuzumab Vedotin, Rituximab, Lenalidomide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Yan Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Yan Zhang, MD

associate director of department of hematology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yan Zhang, MD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Wang, MD

Role: CONTACT

wangweipumc@163.com

+86 13810131294

Zhaohui Zhu, MD

Role: CONTACT

pumchkyc@126.com

+861069156874

Facility Contacts

Wei Wang, MD

Role: primary

wangweipumc@163.com

+8613810131294

Other Identifiers

2022-PUMCH-A-194

Identifier Type: -

Identifier Source: org_study_id