NCT01336920

Carfilzomib in Treating Patients With Relapsed or Refractory T-Cell Lymphoma

Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of carfilzomib in treating patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) anaplastic lymphoma receptor tyrosine kinase (ALK)+/ALK-, adult T-cell leukemia/lymphoma (ATLL), natural killer (NK)-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U). II. To assess the safety and preliminary efficacy of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell leukemia/lymphoma (ATLL), NK-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U). III. To evaluate nuclear transcription factor kappa-B (NF-kappa B) activation in PTCL tumor tissue and correlate that with response to carfilzomib, a novel proteosome inhibitor, which targets NF-kappa B. OUTLINE: This is a dose escalation study. Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for year 1, then every 4 months for year 2, then every 6 months for years 3 and 4, and then yearly thereafter.

Conditions

• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Peripheral T-cell Lymphoma
• Recurrent Adult T-cell Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	carfilzomib	Given IV

Timeline

• Start date: 2011-06-21
• Primary completion: 2015-04-01
• Completion: 2018-03-01
• First posted: 2011-04-18
• Last updated: 2023-09-15

Locations

3 sites across 1 country: United States