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On 9 May 2019, Paolo Strati from the MD Anderson Cancer Center, Houston, TX, USA, and colleagues, published in Haematologica1 results from a phase I clinical trial, investigating the safety and tolerability of alisertib and romidepsin in aggressive B-cell and T-cell lymphomas.
Alisertib is an aurora A kinase inhibitor, which exerts its function by disrupting tumor cell division. Pre-clinical and phase II studies have indicated alisertib’s anti-tumor activity against various haematological malignancies, including B-cell and T-cell non-Hodgkin lymphomas.2,3 Romidepsin, a class I histone deacetylase inhibitor induces cell cycle arrest and has been approved by the Food and Drug Association for the treatment of relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL).
In this open-label, single-center, phase I trial (NCT01897012), patients with aggressive R/R B-cell or T-cell lymphoma were treated with alisertib and romidepsin combination. The primary endpoint of the study was toassess the safety profile of the combination treatment and to determine the the maximum tolerated dose (MTD). Secondary endpoints included overall response rate (ORR) and complete response (CR) rate.
Dose level (DL) |
Time between treatment cycles |
Alisertib |
Romidepsin |
||
---|---|---|---|---|---|
|
|
Dose |
Cycle days |
Dose |
Cycle days |
Level 1 (n = 3) |
21 days |
20 mg BID |
1–7 |
8 mg/m2 |
1,8 |
Level 2 (n = 3) |
21 days |
20 mg BID |
1–7 |
10 mg/m2 |
1,8 |
Level 3 (n = 3) |
21 days |
40 mg BID |
1–7 |
10 mg/m2 |
1,8 |
Level 4 (n = 3) |
21 days |
40 mg BID |
1–7 |
12 mg/m2 |
1,8 |
Level 5 (n = 3) |
28 days |
20 mg BID |
1–3; 8–10; 15–17 |
10 mg/m2 |
2, 9, 16 |
Level 6 (n = 3) |
28 days |
30 mg BID |
1–3; 8–10; 15–17 |
10 mg/m2 |
2, 9, 16 |
Level 7 (n = 3) |
28 days |
30 mg BID |
1–3; 8–10; 15–17 |
12 mg/m2 |
2, 9, 16 |
Level 8 (n = 3) |
28 days |
40 mg BID |
1–3; 8–10; 15–17 |
12 mg/m2 |
2, 9, 16 |
Although the combination of alisertib and romidepsin followed an expected safety profile with no observed DLTs, the preliminary efficacy of the treatment was low in this heavily pre-treated patient population with R/R T-cell or B-cell lymphomas (ORR: 28%) with the exception of patients with HL (ORR: 71%)
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