Combo shows early promise for T-cell lymphomas

The patients received treatment as follows:

• Alisertib at 20 mg orally twice daily on days 1-7 and romidepsin at 6 mg/m² IV on days 1 and 8
• Alisertib at 20 mg orally twice daily on days 1-7 and romidepsin at 8 mg/m² IV on days 1 and 8
• Alisertib at 20 mg orally twice daily on days 1-7 and romidepsin at 10 mg/m² IV on days 1 and 8
• Alisertib at 40 mg orally twice daily on days 1-7 and romidepsin at 10 mg/m² IV on days 1 and 8
• Alisertib at 40 mg orally twice daily on days 1-7 and romidepsin at 12 mg/m² IV on days 1 and 8
• Alisertib at 40 mg orally twice daily on days 1-7 and romidepsin at 14 mg/m² IV on days 1 and 8.

The maximum-tolerated dose has not yet been reached. The main side effect was reversible myelosuppression. In the 24 cycles administered, patients experienced grade 3/4 neutropenia (62.5%), anemia (29%), and thrombocytopenia (48%).

Dr Fanale noted that 3 of the 4 patients with T-cell lymphomas had some level of clinical benefit after therapy.

One patient, a heavily pretreated patient with PTCL who was treated at the lowest dose, had a complete response lasting 10 months. The patient had received 7 prior lines of therapy, including romidepsin alone.

Two other patients had stable disease, one with PTCL and one with an overlap diagnosis of B-cell and T-cell lymphoma. The PTCL patient went on to receive a matched, unrelated-donor transplant and is doing well, Dr Fanale said.

“We’ve taken a pause from this clinical trial,” she added. “We plan to reopen it toward T-cell lymphoma patients, potentially exclusively, . . . and also potentially to change a bit of the dosing schema with both romidepsin and alisertib.”