A PHASE 3, RANDOMIZED, TWO-ARM, OPEN-LABEL, MULTICENTER, INTERNATIONAL TRIAL OF ALISERTIB (MLN8237) OR INVESTIGATOR´S CHOKE (SELECTED SINGLE AGENT) IN PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
- Registration Number
- PER-061-12
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 4
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. INCLUDES LOCAL PATHOLOGIC DIAGNOSIS FROM THE FOLLOWING SUBTYPES:
• PERIPHERAL T-CELL LYMPHOMA, NOS
• ANAPLASTIC LARGE CELL LYMPHOMA (ALK-1 NEGATIVE OR POSITIVE)
• ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA
• ENTEROPATHY-ASSOCIATED T-CELL LYMPHOMA
• HEPATOSPLENIC T-CELL LYMPHOMA
• SUBCUTANEOUS PANNICULITIS-LIKE T-CELL LYMPHOMA
• TRANSFORMED MYCOSIS FUNGOIDES
• EXTRANODAL NK/T-CELL LYMPHOMA NASAL TYPE, AND NK-/T-CELL LYMPHOMA, NASAL
• BLASTIC NK LYMPHOMA
3. TUMOR BIOPSY AVAILABLE FOR CENTRAL HEMATOPATHOLOGIC REVIEW:
• ARCHIVED SAMPLE OR BIOPSY AT SCREENING IF NO PRIOR SAMPLE AVAILABLE (BY NEEDLE CORE BIOPSY OR EXCISIONAL, NOT FINE NEEDLE ASPIRATE); HISTOLOGICAL DIAGNOSIS MADE BY LOCAL PATHOLOGIST WILL BE CENTRALLY REVIEWED FOLLOWING STUDY ENTRY
1. KNOWN CENTRAL NERVOUS SYSTEM (CNS) LYMPHOMA (NOTE: COMPUTED TOMOGRAPHY [CT] OR MAGNETIC RESONANCE IMAGING [MRI] SCANS ARE REQUIRED ONLY IF BRAIN METASTASIS IS SUSPECTED CLINICALLY) [ROMIDEPSIN]
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 GEMEITABINE
5. HISTORY OF UNCONTROLLED SLEEP APNEA SYNDROME OR OTHER CONDITIONS THAT COULD RESULT IN EXCESSIVE DAYTIME SLEEPINESS, SUCH AS SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6. HISTORY OF HEMORRHAGIC OR THROMBOTIC CEREBROVASCULAR EVENT IN THE PAST 12 MONTHS
7. MYOCARDIAL INFARCTION WITHIN 6 MONTHS OF CLDLOR HISTORY OF NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE, UNCONTROLLED ANGINA, SEVERE UNCONTROLLED VENTRICULAR ARBYTHMIAS, OR ECG EVIDENCE OF ACUTE ISCHEMIA (HEART DISEASE)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method