A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Phase 3

Completed

Conditions: Peripheral T-cel lymphoma
10025321

Registration Number: NL-OMON39884

Lead Sponsor: Millenium Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

1. Male or females, age * 18 years
2. Patients with PTCL according to WHO criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy (ie, experimental therapy may not be the only prior therapy). Cutaneous-only disease is not permitted. Patients must have documented evidence of progressive disease
3. Tumor biopsy available for central hematopathologic review
4. Measurable disease according to the IWG criteria (See Section 15.4). Patients must have at least 1 site of disease measurable in 2 dimensions by computed tomography (CT)
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;Please see protocol for all inclusion criteria

Exclusion Criteria

1. Known central nervous system (CNS) lymphoma
2. Systemic antineoplastic therapy, immunotherapy, investigational agent, or radiation therapy within 4 weeks of first dose of study treatment (6 weeks if nitrosoureas given) or concomitant use during study
3. Prior administration of an Aurora A kinase-targeted agent, including alisertib
4. Prior administration (whether in combination or as single-agent) of all 3 of the comparator drugs for the disease under study: pralatrexate, romidepsin, and gemcitabine;Please see protocol for all exclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>ORR: CR + PR based on independent review committee (IRC) assessment using the<br /><br>IWG criteria.<br /><br>PFS based on IRC assessment using the IWG criteria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The key secondary endpoints are:<br /><br>* CR rate<br /><br>* Overall survival<br /><br><br /><br>Other secondary endpoints include:<br /><br>* Adverse events (AEs), serious adverse events (SAEs), assessments of clinical<br /><br>laboratory values and clinically important laboratory abnormalities, and vital<br /><br>sign measurements<br /><br>* Time to disease progression<br /><br>* Duration of response<br /><br>* Time to response<br /><br>* Time to subsequent antineoplastic therapy<br /><br>* Plasma concentration-time data to contribute to future population PK analysis<br /><br>* Changes in reported symptoms and QOL assessment per FACT-Lym for functioning<br /><br>and symptoms </p><br>