Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

• Status: Completed
• Trial end date: 2017-12-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Aminopterin; Gemcitabine; Romidepsin

Criteria

Inclusion Criteria:

• Male or female participants age 18 or older

• Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease.

• Tumor biopsy available for central hematopathologic review

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Female participants 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 participants 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

Exclusion Criteria

• Known central nervous system lymphoma

• 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

• Participants 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

• Participants 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 participant must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to participant'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 participants 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