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NCT Number: NCT06176729

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

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).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Wei Wang, MD

CONTACT

[email protected]

+8613810131294

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polatuzumab Vedotin, Rituximab, Lenalidomide

Drug

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

Primary outcomes

  1. complete remission rate

    Time frame: evaluated every 3 months,up to 24 months

    proportion of patients achieving complete remission

Secondary outcomes

  1. overall remission rate

    Time frame: evaluated every 3 months,up to 24 months

    proportion of patients achieving at least partial remission

  2. 2 year progression-free survival rate

    Time frame: 2 years after last patient included

    time from treatment to the time of disease progression or death of any reason

  3. 2 year overall survival rate

    Time frame: 2 years after last patient included

    time from treatment to the time of death of any reason

  4. any adverse event occurred during this study

    Time frame: 2 years after last patient included

    safety

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Wang, MD

CONTACT

[email protected]

+86 13810131294

Zhaohui Zhu, MD

CONTACT

[email protected]

+861069156874

Sponsors and collaborators

Lead sponsor

Yan Zhang, MD

Other

Collaborators

  • Chinese PLA General Hospital
  • Peking University First Hospital
  • Peking University Third Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 20, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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