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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176729
• Other study ID #: 2022-PUMCH-A-194
• Status: Recruiting
• Phase: Phase 2
• Start date: October 24, 2023
• Est. completion date: October 24, 2027

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: Wei Wang, MD
• Phone: +86 13810131294
• Email: wangweipumc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 24, 2027
• Est. primary completion date: October 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Yan Zhang, MD	Chinese PLA General Hospital, Peking University First Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate	proportion of patients achieving complete remission	evaluated every 3 months,up to 24 months
Secondary	overall remission rate	proportion of patients achieving at least partial remission	evaluated every 3 months,up to 24 months
Secondary	2 year progression-free survival rate	time from treatment to the time of disease progression or death of any reason	2 years after last patient included
Secondary	2 year overall survival rate	time from treatment to the time of death of any reason	2 years after last patient included
Secondary	any adverse event occurred during this study	safety	2 years after last patient included