Diffuse Large B Cell Lymphoma
Conditions
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.
Interventions
DRUGPolatuzumab 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
Sponsors
Peking University Third Hospital
Peking University First Hospital
Chinese PLA General Hospital
Yan Zhang, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | evaluated every 3 months，up to 24 months | proportion of patients achieving complete remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall remission rate | evaluated every 3 months，up to 24 months | proportion of patients achieving at least partial remission |
| 2 year progression-free survival rate | 2 years after last patient included | time from treatment to the time of disease progression or death of any reason |
| 2 year overall survival rate | 2 years after last patient included | time from treatment to the time of death of any reason |
| any adverse event occurred during this study | 2 years after last patient included | safety |
Countries
China
Contacts
Primary ContactWei Wang, MD
Backup ContactZhaohui Zhu, MD
Outcome results
None listed