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Complete title: A Phase 3 Randomized, Two-Arm, Open Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigators Choice (Selected Single Agent) in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
|Research Study Number||20120291|
|Principal Investigator||Andrei Shustov, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Male or female patients age 18 or older
- Patients with PTCL according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease.
- Tumor biopsy available for central hematopathologic review
- Measurable disease according to the IWG criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
- Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
- Suitable venous access
- Voluntary written consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
- Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity)
- History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
- Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
- Concomitant use of other medicines as specified in study protocol
- Patients with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
- Autologous stem cell transplant less than 3 months prior to enrollment
- Patients who have undergone allogeneic stem cell or organ transplantation any time
- Inadequate blood levels, bone marrow or other organ function as specified in study protocol
- The patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade = /<1 toxicity, to patients's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
- Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
- Female patients who are breastfeeding or pregnant
- Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
- Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma; Lymphoproliferative Disease; Non-Hodgkin's Lymphoma (NHL)
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