Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorSun Yat-sen University

About this trial

This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.

Eligibility criteria

Qualifiers

Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;

Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).

Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.

At least one measurable or evaluable lesion according to the Lugano 2014 criteria.

Disqualifiers

Other subtypes of DLBCL.

Lymphoma involvement in the central nervous system or meninges.

Active infections.

History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).

Trial design

Treatments tested in this trial

  • Polatuzumab Vedotin
  • Rituximab (R)
  • Chidamide

Treatment groups

68 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators