Phase 1b Study Examines Acalabrutinib Triplet in MCL

Michael Wang, MD, discusses the study design of the ongoing, multicenter, open-label study examining an acalabrutinib triplet in MCL.

Michael Wang, MD, a professor in the department of lymphoma and myeloma at MD Anderson Cancer Center, discusses the study design of the ongoing, multicenter, open-label study (NCT02717624).

The study examined the combination of acalabrutinib (Calquence) plus venetoclax (Venclexta), and rituximab (Rituxan) in patients with treatment naïve mantle cell lymphoma (MCL) who are unable to receive chemotherapy.

The target enrollment for the trial was 20-30 patients with MCL who had not been treated prior and the number of patients with treatment emergent adverse events was the primary end point. Participants were given acalabrutinib between day 1 of cycle 1 at 100 mg until disease progression or intolerance, venetoclax on day 1 of cycle 2 with dose escalation through cycle 5 to 25, and rituximab on day 1 of every cycle for 6 cycles followed by every other cycle until cycle 24.

Transcription:

0:08 | The study was designed to enroll 20 to 30 patients with MCL who never treated it before. The primary end point is the safety analysis, and the secondary objectives include efficacy, complete response, partial response, and overall response. Acalabrutinib was given from cycle 1 day 1 at 100 mg BID, until disease progression or intolerance. Venetoclax was given on cycle 2 day 1 with a 5 week ramp up period of dose escalation through cycle 5 to 25. Rituximab was given on day 1 of every cycle for 6 cycles and then after that, every other cycle until cycle 24. So, this is how dose limiting toxicity was assessed from cycle 2 day 1 to cycle 3, day 2.