Clinical trial · Interventional
Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma
NCT00807495CI-TRIAL-00032250completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
| Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alisertib | Drug | Alisertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alisertib 50 mg
- description
- Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months or longer with Sponsor approval).
- interventionNames
- Drug: Alisertib
Primary outcomes (1)
- measure
- Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria)
- timeFrame
- Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)
- description
- Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Participant must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy: * Diffuse large B-cell lymphoma * Mantle cell lymphoma * Burkitt's lymphoma * Precursor B-lymphoblastic leukemia/lymphoma * T-cell lymphoma, excluding primary cutaneous T-cell lymphoma * Transformed follicular lymphoma with ≥ 50% diffuse large cell component. 2. Male or female participants 18 years or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Measurable disease. Exclusion criteria include the following: 1. Pregnant or lactating females. 2. Known human immunodeficiency virus (HIV) positive or AIDS-related illness. 3. Any serious medical or psychiatric illness that could interfere with the completion of treatment. 4. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN). 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder. 6. Absolute neutrophil count (ANC) \< 1,250/mm\^3. 7. Platelet count \< 75,000/mm\^3. 8. Calculated creatinine clearance \< 30 mL/minute. 9. Autologous stem cell transplant less than 6 months prior to enrollment. 10. Participants who have undergone allogeneic stem cell or organ transplantation. 11. Systemic antineoplastic therapy including glucocorticoids (\> 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment. 12. Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose. 13. Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose. 14. Participants who have received radiotherapy within 21 days prior to first dose. 15. Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia. 16. Major surgery within 14 days prior to the first dose. 17. Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection. 18. Clinically uncontrolled central nervous system (CNS) involvement. 19. Inability to swallow capsules. 20. History of uncontrolled sleep apnoea syndrome and other conditions that could result in excessive daytime sleepiness (eg, Chronic obstructive pulmonary disease - COPD).
References
Publications (1)
- RESULTCheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22. PMID 17242396