Recurrent and Refractory Diffuse Large B-cell Lymphoma
Conditions
Brief summary
The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma. .The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles. .Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.
Interventions
DRUGPurinostat Mesylate for Injection
The subjects in the experimental group will receive treatment with Purinostat Mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous infusion on days 1, 4, 8, and 11. The administration cycle lasts for 21 days, and the total treatment cycle is 6 cycles. After 6 cycles, the investigator will assess whether the subjects can continue to benefit, whether they can sustain the treatment with the investigational drug, and adjust the frequency of continuous administration based on the evaluation results of the efficacy over these 6 cycles.
The recommended dose of selinexor tablets is 60 mg per administration, taken orally on the 1st and 3rd day of each week (for example, Monday and Wednesday, or Tuesday and Thursday), with a 4-week course as one treatment cycle. Patients who achieve partial response (judged by the investigator as the best expected response for the subject) or have better efficacy can switch to maintenance treatment, with a maintenance dose of 60 mg taken orally once a week.
Sponsors
Chengdu Zenitar Biomedical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, no gender restrictions; 2. Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines); 3. Participants must have measurable disease; 4. ECOG≤2; 5. Adequate organ function
Exclusion criteria
1. Pregnancy or breastfeeding; 2. Previous history of transplantation; 3. Double/Triple Hit B cell lymphoma; 4. Patient with known active infection, or reactivation of a latent infection; 5. Any serious diseases that investigator deems inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Survival | week 96 | The Overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The PFS assessed by BICR AND Investigator according to Lugano 2014 | week 96 | The PFS assessed by BICR AND Investigator according to Lugano 2014 |
| The ORR assessed by BICR and Investigator according to Lugano 2014 | week 96 | The ORR assessed by BICR and Investigator according to Lugano 2014 |
Countries
China
Contacts
Primary ContactLiangkun Sun
Outcome results
None listed