MLN8237 + Rituximab + Vincristine PhII open label in B-Cell Lymphoma
Research type
Research Study
Full title
A Multicenter, Phase 1-2 Study of MLN8237, an Oral Aurora A Kinase Inhibitor, in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab and Vincristine
IRAS ID
103221
Contact name
Andrew Davies
Sponsor organisation
Millennium Pharmaceuticals, Inc
Eudract number
2011-000609-32
Clinicaltrials.gov Identifier
Research summary
Phase 1/2 open-label (both patients and study doctor/team know which treatment is given/taken) study done to find out whether MLN8237 (alisertib or M) has any benefit when given in combination with rituximab and vincristine (MVR) to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and/or transformed follicular lymphoma (TFL). UK only participates in Phase 2 where the MRV conbination dose will be studied for safety, tolerability and measurament of anti-tumour activities. Alisertib (M) has been developed to interfere with cell division which is required for normal and cancer cell growth. When a single cell divides into two new cells, its chromosomes (genetic material) must be divided equally between the cells. Aurora A kinase is the enzyme that controls the distribution of the new chromosomes into each of the new cells. Alisertib works by blocking Aurora A kinase. The blocking of Aurora A kinase may interfere with dividing cells, thereby, slowing cancer growth and causing cancer cell death. Alisertib is currently being studied in patients with advanced solid tumour cancers as well as patients with blood related cancers. Rituximab and vincristine are approved drugs for the treatment of DLBCL/TFL(blood and bone marrow cancers). Approximately 60 patients Male and/or female patients 18= years of age who have histologically confirmed DLBCL/TFL will receive the MRV combination at 20-22 sites in the USA and Europe. Eligible patients will be placed in the study and start taking MRV for up to 8 cycles (21 days each). After Cycle 8, if their cancer has responded or stabilized they may be allowed to continue taking alisertib on its own for up to 32 cycles (approximately 24 months). Upon request by the investigator and agreement by the sponsor, treatment beyond 2 years with alisertib may be permitted in patients that benefit from it.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
12/NE/0268
Date of REC Opinion
6 Sep 2012
REC opinion
Further Information Favourable Opinion