NCT02572453

Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL

Phase 2 Trial of the Heat Shock Protein-90 (Hsp90) Inhibitor AT13387 (Onalespib) in Patients With Relapsed/Refractory ALK+ ALCL, Mantle Cell Lymphoma, and BCL6+ DLBCL

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well onalespib works in treating patients with anaplastic large cell lymphoma, mantle cell lymphoma, or diffuse large B-cell lymphoma that has not responded to previous treatment (refractory) or that has returned after a period of improvement (recurrent). Onalespib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. Overall response rate (ORR) to single agent AT13387 (onalespib) as measured by the proportion of partial and complete responses (PR + CR) in patients with relapsed/refractory ALK positive (+) anaplastic large cell lymphoma (ALCL), mantle cell lymphoma (MCL), and BCL6+ diffuse large B cell lymphoma (DLBCL). SECONDARY OBJECTIVES: I. Progression free survival (PFS) and overall survival (OS), as well as duration of response (DOR) of single agent AT13387 (onalespib) in patients with ALK+ ALCL, MCL, and BCL6+ DLBCL. II. Safety and tolerability of single agent AT13387 (onalespib) in patients with ALK+ ALCL, MCL, and BCL6+ DLBCL. EXPLORATORY OBJECTIVES: I. Measurement of on-target activity of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL6+ DLBCL through immunoblotting and immunohistochemistry of pre-treatment, on-treatment, and time of progression tumor biopsies for HSP90 clients. II. Determination of genetic and transcriptional markers for response and resistance to AT13387 (onalespib) in patients with ALK+ ALCL, MCL, and BCL6+ DLBCL. OUTLINE: Patients receive onalespib intravenously (IV) over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 1 year.

Conditions

• Recurrent Anaplastic Large Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma
• Refractory Anaplastic Large Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Transformed Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Onalespib	Given IV

Timeline

• Start date: 2016-04-04
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2015-10-09
• Last updated: 2022-09-13
• Results posted: 2022-09-13

Locations

19 sites across 1 country: United States