Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase Ib/II Trial of Combination RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia
This is an open-label, multicenter, phase Ib/II study of the combination of RP-3500 and olaparib in R/R CLL patients with DDR deficiencies.
The Phase Ib part of the trial will seek to assess the MTD of camonsertib (RP-3500) in combination with olaparib. Given the potential overlapping toxicities of RP-3500 and olaparib, a keyboard phase I design, a novel Bayesian method that typically underestimates the MTD,61 will be employed. The target toxicity is 30% with an equivalence interval between 25-33% of patients. With an anticipated 3 dose levels (DL) and an option for a DL-1, up to 18 patients may be required to determine the MTD. A maximum of 12 patients will be treated at a DL. The first 5 patients treated at the previous DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 3 days per week) determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing may be necessary to increase safety of the combination therapy. Therefore, the newly proposed DLs will seek to enroll an additional 18 patients. After completion of the phase Ib portion and assignment of the RP2D, continuous enrollment of patients may commence into the phase II dose expansion portion. All patients enrolled at the RP2D during the phase Ib dose-escalation portion of the trial can be carried over into the phase II analysis. The maximum number of patients that can be carried over from the dose escalation to the dose-expansion portion is 12. The phase II dose expansion will consist of two separate cohorts of subjects: an enrichment cohort and a cohort for all other eligible subjects. All subjects enrolled into the enrichment cohort must have a del(11q) and/or ATM mutation. Eight subjects will be enrolled into the enrichment cohort and 16 will be enrolled into the second cohort for a total phase II cohort of 24 patients. ;
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