This trial is a proof-of-concept, pilot study, phase I/II clinical trial aimed at generating preliminary data on the combination of golcadomide, poseltinib, and rituximab.
Subjects must satisfy the following criteria to be enrolled in the study
Subject is ≥ 19 years of age at the time of signing the informed consent form (CRF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Subject who has had prior treatment with golcadomide.
Subject who has had prior treatment with BTK inhibitor.
Subject has life expectancy ≤ 2 months.
Subject has previously received solid organ transplantation.
Single group
Golcadomide + Poseltinib + Rituximab
DrugParticipants will receive 0.4 mg of golcadomide once daily for 14 consecutive days for 18 cycles in 28-day cycles. The first 6 cycles will be administered in combination with rituximab and poseltinib, while the remaining 12 cycles will be conducted with poseltinib alone. During the maintenance period (Cycles 7-18), the first day of study treatment administration with golcadomide is designated as Day 1 of each cycle. Rituximab can be administered with or up to 2 hours after the morning dose of golcadomide in the fed or fasted state. For Cycles 1-6, the first day of study treatment administration with rituximab is designated as Day 1 of each cycle. Rituximab will be administered as an IV infusion at a dose of 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1, and Day 1 of Cycles 2-6. Poseltinib is administered orally twice daily, approximately every 12 hour. Part 1 (safety cohort) of the study will be conducted in up to approximately 9 participants to select the optimal RP2D of poseltinib.
Overall response rate (ORR)
The primary endpoint was the Overall response rate, defined as the proportion of participants who achieved either CMR or PMR according to the Lugano criteria 2014. The primary analysis will be conducted in the efficacy evaluable population. A one-sample exact binomial test (one-sided, α=0.05) will be used to compare the observed ORR against the null hypothesis value of 30%. If the lower bound of the exact one-sided 95% CI for the observed ORR exceeds 30%, the null hypothesis will be rejected, suggesting that the combination therapy demonstrates meaningful efficacy.
Progression-free survival (PFS)
PFS is calculated as the time from enrollment to the first documented progression confirmed or death due to any cause, whichever occurs first. Response assessments will be based on the Lugano criteria 2014. PFS analysis will follow the censoring rules based on Food and Drug Administration (FDA) guideline (2018) as the primary analysis method. Specifically, subjects who initiated other anti-lymphoma therapy without documented PD will be censored at last adequate assessment prior to the initiation of other anti-lymphoma therapy. Subjects with two or more consecutive missed assessments prior to documented PD or death will be censored at the last adequate assessment prior to the missing assessment. The Kaplan-Meier method will be used to estimate the survival distribution functions. The median PFS along with the two-sided 95% CI for the median will be estimated.
Overall survival (OS)
OS is calculated as the time from randomization to death from any cause. Subjects who died will be considered as having OS events on the date of death. All subjects who are lost to follow-up prior to the date of the data cut-off or who withdrew consent from the trial will be censored at the last date known to be alive. Subjects who are still in the study at the date of data cut-off will be censored at the last available date that the subject is known to be alive, or data cut-off date, whichever is earlier. The analysis of OS will be based on all data available. The median OS along with the two-sided 95% confidence interval for the median will be estimated.
Complete metabolic response (CMR) rate
The CMR rate is the proportion of subjects who achieve CMR according to the Lugano criteria 2014.
Duration of response (DOR)
DoR is calculated as the time from first documentation of response (CMR or PMR) to the first documented progression confirmed, start of new anti-lymphoma therapy, or death due to any cause, whichever occurs first. Response assessments will be based on the Lugano criteria 2014. The analysis will be conducted in patients who achieved a documented response. The Kaplan-Meier method will be used to estimate the survival distribution functions for each treatment arm. The median DoR along with the two-sided 95% confidence interval for the median will be estimated.
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