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Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia

2014-08-27 03:13:09 | BioPortfolio

Summary

This study is to test escalating doses of carfilzomib in patients with relapsed acute myeloid and acute lymphoblastic leukemia.

Description

- To determine the maximum tolerated dose and dose limiting toxicity of carfilzomib in adult patients with relapsed acute myeloid and acute lymphoblastic leukemia.

- To determine the rate of morphologic complete remission (CR) of carfilzomib in adult patients with relapsed acute myeloid and acute lymphoblastic leukemia.

- To determine the rates of cytogenetic complete remission (CRc) morphologic complete remission with incomplete count recovery (CRi), overall response rate (CR+ CRi), partial remission (PR), stable disease and hematologic improvement.

- To determine the time to response, remission duration, progression-free survival, event-free survival and overall survival of patients treated with carfilzomib.

- To determine the safety and tolerability of carfilzomib.

- To prospectively collect serum and bone marrow specimens to determine biomarkers of response and correlative ex vivo studies of the anti-leukemic activity of carfilzomib.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

Carfilzomib, Carfilzomib, Carfilzomib

Location

Washington University School of Medicine
St. Louis
Missouri
United States
63110

Status

Not yet recruiting

Source

Washington University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:09-0400

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Medical and Biotech [MESH] Definitions

A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.

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A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

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