NCI/CTEP# 9875: Phase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL.

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NCI/CTEP# 9875: Phase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL.

Primary Objectives:

1.1.1 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+ anaplastic large cell lymphoma (ALCL), mantle cell lymphoma (MCL), and BCL6+ diffuse large B cell lymphoma (DLBCL).

Secondary Objectives:
1.2.1 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.

1.2.2 Safety and tolerability of single agent AT13387 (onalespib) in patients with ALK+ ALCL, MCL, and BCL6+ DLBCL.

Exploratory Objectives
1.3.1 Measurement of on-target activity of AT13387 (onalespib) in ALK+ ALCL, MCL,and BCL6+ DLBCL through immunoblotting and immunohistochemistry of pretreatment,on-treatment, and time of progression tumor biopsies for HSP90 clients.

1.3.2 Determination of genetic and transcriptional markers for response and resistance to AT13387 (onalespib) in patients with ALK+ ALCL, MCL, and BCL6+ DLBCL.

Protocol Number: 011703
Phase: Phase II
Applicable Disease Sites: Non-Hodgkin's Lymphoma
Drugs Involved: AT13387 (onalespib)
Principal Investigator: Kevin David
Research Nurse: Jennifer Lee
Scope: National
Therapies Involved: Chemotherapy (NOS)
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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