DLBCL - Diffuse Large B Cell Lymphoma, TP53
Conditions
Brief summary
To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
Detailed description
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
Interventions
DRUGAzacitidine in combination with R-CHOP
Specified dose on specified days: Azacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg/m2 IV d0 Cyclophosphamide (C) 750mg/m2 IV d1 epirubicin (H) 75mg/m2 IV d1 or liposomal adriamycin (D) 25-30mg/m2 IV d1 Vincristine (O) 1.4mg/m2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5
Sponsors
Jiangsu Provincial People's Hospital
Sun Yat-sen University
Chinese Academy of Medical Sciences
Shanxi Province Cancer Hospital
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.
Exclusion criteria
1. Primary and secondary central DLBCL; 2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease; 4\) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate (CR) | Up to 36 months | CR is evaluated according to the Lugano criteria for lymphoma response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial remission rate (PR) | Up to 36 months | PR is evaluated according to the Lugano criteria for lymphoma response. |
| Overall response rate (ORR) | Up to 36 months | Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria. |
| Progression Free Survival (PFS) | Up to 36 months | The Kaplan-Meier method will be used to estimate the rate of PFS. PFS was defined as the time from the date of treatment initiation until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. |
Countries
China
Contacts
Primary ContactBing Xu
Backup ContactZhifeng Li
Outcome results
None listed