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This study is to test escalating doses of carfilzomib in patients with relapsed acute myeloid and acute lymphoblastic leukemia.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Carfilzomib, Carfilzomib, Carfilzomib
Washington University School of Medicine
Not yet recruiting
Washington University School of Medicine
Published on BioPortfolio: 2014-08-27T03:13:09-0400
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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.
A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.
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