NCT02700022

A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas

A Phase I/Ib Study of Alisertib Plus R-EPOCH for Treatment of Myc-Positive Aggressive B-Cell Lymphomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD, which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for Myc gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle of R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL population will be opened to further characterize clinical activity and safety. Secondary objectives include estimates of complete response rate (CR) and progression free survival (PFS). We will also explore for associations between baseline kinome signatures and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to and during treatment.

Conditions

• Diffuse Large B-cell Lymphoma
• Follicular Lymphoma
• Burkitt Lymphoma

Interventions

Type	Name	Description
DRUG	Alisertib	Dose escalation of alisertib: level 1 - 20 mg, level 2 - 30 mg, level 3 - 40 mg PO BID on Days 1-5 of six 21-day cycles, combined with R-EPOCH Rituximab, IV infusion on day 1 of each cycle; Etoposide, IV infusion for 96 hours on days 1, 2, 3, and 4 Doxorubicin, IV infusion for 96 hours on days 1, 2, 3, and 4 Vincristine, IV infusion for 96 hours on days 1, 2, 3, and 4 Cyclophosphamide, IV infusion for 15 minutes on day 5 Prednisone, PO daily on days 1, 2, 3, 4, and 5

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-15
• Completion: 2017-08-18
• First posted: 2016-03-07
• Last updated: 2017-11-20

Locations

2 sites across 1 country: United States