Polatuzumab Vedotin in Combination with Rituximab and mini-CHP Therapy for Untreated 80 Years or Older Patients with Diffuse Large B-cell Lymphoma, Multicenter Phase II Trial

JRCT ID: jRCTs041230146

Registered date:06/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diffuse Large B-cell Lymphoma
• Date of first enrollment: 06/02/2024
• Target sample size: 66
• Study type: Interventional
• Intervention(s): Pola-R-miniCHP therapy is administered one cycle at 3-week intervals for a total of six cycles. Pola-R-miniCHP therapy consists of polatuzumab vedotin 1.8 mg/kg, rituximab 375 mg/m2, doxorubicin 25 mg/m2, cyclophosphamide 400 mg/m2 on day 1 and prednisolone 40 mg/m2 from day 1 to day 5.

Outcome(s)

• Primary Outcome: 2 years Progression-free Survival

Secondary Outcome

2 years Over-all Survival
Complete Metabolic Response Rate
Over-all Response (Complete Metabolic Response, Partial Metabolic Response) Rate

2 years Progression-free Survival
2 years Progression-free Survival by Cell of Origin
2 years Over-all Survival by Cell of Origin
Complete Metabolic Response Rate by Cell of Origin
Over-all Response (Complete Metabolic Response, Partial Metabolic Response) Rate by Cell of Origin
2 years CNS relapse rate by Cell of Origin

Adverse Events
Febrile Neutropenia Incidence Rate
Infetious Disease Incidence Rate without Febrile Neutropenia
Peripheral Neuropathy Incidence Rate and Their Transition
Incidence Rate of Hepatitis B Virus Reactivation
Incidence Rate of Herpes Zoster Virus Reactivation (Shingles) by Herpes Zoster vaccine status
Fracture Incidence Rate

Key inclusion & exclusion criteria

• Age minimum: >= 80age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with CD20-positive diffuse large B-cell lymphoma (the following diagnoses included in large B-cell lymphoma according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, Revised 4th Edition) with no prior treatment and histopathology confirmed by biopsy specimen from the lymphoma lesion.
Diffuse large B-cell lymphoma, NOS (regardless of GCB or ABC type)
Primary mediastinal (thymic) large B-cell lymphoma
T-cell/histiocyte-rich large B-cell lymphoma
High-grade B-cell lymphoma, NOS
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
(2) Performance status 0 to 2 according to ECOG performance status
(3) Patients 80 years or older on the date of consent
(4) Patients with clinical stage (Ann-Arbor classification) stage I with bulky lesions(>= 7.5 cm in CT horizontal section images) and stage II-IV
(5) Patients with measurable lesions (measurable lesions are defined as lymph node or extranodal lesions with a maximum diameter of 16 mm or greater that are clearly measurable in two orthogonal directions on CT horizontal section images; bone lesions only are defined as non-measurable lesions)
(6) The most recent laboratory examinations within 28 days prior to entry must meet all of the following (the same day 4 weeks prior to entry is also acceptable)
Neutrophil count >= 1,000/microL (>= 500/microL in case of bone marrow involvement of lymphoma)
Platelet count >= 75,000/microL (>= 50,000/microL in case of bone marrow involvement of lymphoma)
Hemoglobin >= 10.0 g/dL (>= 8.0 g/dL in case of bone marrow involvement of lymphoma)
AST <= 100 U/L
ALT <= 100 U/L
Total bilirubin <= 2.0 mg/dL (patients with Gilbert's syndrome are allowed up to 4.8 mg/dL)
Serum creatinine <= 2.0 mg/dL
SPO2 at room air >= 93%
(7) Patients with a left ventricular ejection fraction of 50% or greater on echocardiogram at the institution
(8) Patients who consent to participate in this study

Exclude criteria

(1) Patients with any of the following disease types included in the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, Revised 4th Edition
Primary diffuse large B-cell lymphoma of the central nervous system
Primary diffuse large B-cell lymphoma of the testis
Primary cutaneous diffuse large B-cell lymphoma, leg type
EBV-positive diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma associated with chronic inflammation
Lymphomatoid granulomatosis
Intravascular large B-cell lymphoma
ALK-positive large B-cell lymphoma
Plasmablastic lymphoma
Primary effusion lymphoma
B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma
Large B-cell lymphoma with IRF4 rearrangement
Burkitt-like lymphoma with 11q aberration
Burkitt lymphoma
(2) Transformation from low-grade lymphoma (Small lymphocytic lymphoma, follicular lymphoma, marginal zone lymphoma)
(3) Synchronous active malignancy
(4) Multiple myeloma, leukemia, myeloproliferative neoplasms, myelodysplastic syndrome, or other hematological malignancy, or a history of such hematological malignancy
(5) Patients who do not have a family member or caregiver who can adequately observe the patient on a daily basis
(6) Patients with lesions in the central nervous system
(7) Patients with a positive HCV-RNA test; if HCV antibodies are positive, HCV-RNA is measured and if the HCV-RNA test is negative, the patient is eligible
(8) HBs antigen-positive patients; patients who are HBs antigen negative and anti-HBc antibody positive are eligible if HBV-DNA is not detected
(9) HIV antibody positive
(10) HTLV-1 antibody positive
(11) Uncontrollable hypertension with antihypertensive drugs
(12) Diabetes mellitus poorly controlled by insulin
(13) Uncontrollable Arrhythmia, unstable angina pectoris
(14) Patients with chronic obstructive pulmonary disease and severe restrictive or obstructive ventilation disorders
(15) Patients with a history or findings of clinically significant cardiovascular, respiratory, central nervous system, or other systemic diseases that, in the judgment of the investigator would interfere with the conduct of this study
(16) Patients receiving oral or intravenous steroids for more than 1 month at the time of consent
(17) Patients allergic to polatuzumab vedotin, rituximab, doxorubicin, or cyclophosphamide
(18) Patients with severe mental impairment or cognitive decline due to schizophrenia or Alzheimer's disease
(19) Patients with active infection
(20) Patients who are expected to have difficulty cooperating in the conduct of this study
(21) Patients who are judged by the investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Yoshida Isao
• Source(s) of Monetary Support: Grant-in-Aid for Clinical Research from the National Hospital Organization