All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
Introducing
Now you can personalise
your Lymphoma Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. View funders.
Bookmark this article
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%)
Understanding your specialty helps us to deliver the most relevant and engaging content.
Please spare a moment to share yours.
Please select or type your specialty
Your opinion matters
Subscribe to get the best content related to lymphoma & CLL delivered to your inbox