An Open, Multicenter Phase II Study of the Efficacy and Safety of BEBT-908 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- BEBT-908 for injection
- Conditions
- Relapsed or Refractory Diffuse Large B-cell Lymphoma
- Sponsor
- BeBetter Med Inc
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- ORR
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is an open,single-arm,multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: phase Ⅱa and phase Ⅱb. Phase Ⅱa is an exploratory study, which mainly explores the safe and effective dose and the relationship between gene and protein markers and drug sensitivity. The main purpose of the phase Ⅱb study was to evaluate the Objective response rate of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma, and the secondary study was to evaluate the disease control rate, progression-free survival, time to response, duration of response, overall survival and safety tolerance of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The relationship between the biomarkers of BEBT-908 for injection and the efficacy and safety was evaluated.
Detailed Description
This is an open, single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: Ⅱa and Ⅱb, stage Ⅱa is an exploratory study, which mainly explores the safe and effective dose, 30 cases are planned to be included in the group, stage Ⅱb mainly evaluates the efficacy and safety of BEBT-908 for injection, according to the preliminary overall efficacy analysis of stage Ⅱa, the sample size of stage Ⅱb is about 90 cases. In phase Ⅱa and Ⅱb study, the initial dose was 22.5mg/m2, intravenous drip, 21 days as a cycle and 6 cycles as the total treatment cycle. The drugs were given on the 1st, 3rd, 5th, 8th, 10th and 12th day of each cycle. The study process of each subject included three periods: screening period, treatment period and follow-up period after treatment. During the treatment period, all safety items were examined before administration on the first day of each cycle, and the tumor was evaluated every 2 cycles. After the termination of treatment, the subjects will enter the follow-up period. Receive curative effect follow-up every 6 weeks (to tumor progression or other anti-tumor therapy) and survival follow-up every 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is willing to sign the informed consent form (ICF) after a comprehensive understanding.
- •Age ≥ 18 years and ≤ 75 years, male or female.
- •Diffuse large B-cell lymphoma was confirmed by central pathological examination and tissue biopsy.(Note 1)
- •With measurable lesions.(Note 2)
- •Refractory or relapse after at least two kinds of systematic treatment. (Note 3)
- •Eastern Cooperative Oncology Group (ECOG) score ≤
- •Life expectancy \> 12 weeks.
- •The level of organ function must meet the following requirements:
- •Peripheral blood:
- •Absolute neutrophil count (ANC) ≥ 1000 /μL.
Exclusion Criteria
- •It is known to be severely allergic to research drugs or any of their excipients.
- •Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded:
- •Men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial. Unless follow-up studies confirm reproductive safety.
- •pregnant or lactating women.
- •Primary central nervous system lymphoma or lymphoma invading the central nervous system.
- •Previous transformation of chronic lymphoma (such as Richter syndrome, pre-lymphocytic leukemia, etc.).
- •There are other active malignant tumors that may interfere with this study.
- •Pre-trial treatment:
- •Have received any persistent or intermittent treatment such as Phosphoinositide 3-kinase (PI3K) inhibitors, Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors or other small molecule targeted drugs within 2 weeks before entering the group.
- •Autologous hematopoietic stem cell transplantation within 3 months before enrollment.
Arms & Interventions
BEBT-908 for injection
BEBT-908 for injection, dosage form: injection, specification: 25mg, administration method: the initial dose was 22.5mg/m2, intravenous drip, 3 times a week, 21 days as a cycle, 6 cycles as the total treatment cycle.
Intervention: BEBT-908 for injection
Outcomes
Primary Outcomes
ORR
Time Frame: 6 weeks， assessed up to 24 months.
Objective response rate
Secondary Outcomes
- DCR(Every 6 weeks， assessed up to 24 months.)
- OS(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- PFS(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- TTR(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- DOR(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- AE(From the first administration of the study drug to 30 days after the last administration of the study drug.)