Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia — AML ALL  

Leukemia Clinical Trial

Official title: A Phase I Trial of Carfilzomib in Adult Patients With Relapsed Acute Myeloid and Acute Lymphoblastic Leukemia

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Several published studies have demonstrated the in vitro anti-leukemic activity of carfilzomib in leukemia cell lines as well as in primary human acute myeloid and acute lymphoblastic leukemia cells. The anti-leukemic activity of carfilzomib was consistently more potent than that of bortezomib, particularly at doses ≥27mg/m2. Importantly, patients treated on the phase I and phase II carfilzomib trials have had low rates of treatment-associated neuropathy. Several large collaborative groups have current phase II clinical trials that incorporate bortezomib into the treatment regimens for acute myeloid or acute lymphoblastic leukemia. Thus, there is a strong rationale for a study of carfilzomib, a potentially more potent proteasome inhibitor with less toxicity, in patients with relapsed acute leukemias. ;

Study Design

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT01137747
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Completion date: July 2015