NCT00636155

EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase II Study of EL625 in Patients in Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: David Rizzieri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if the investigational drug EL625, when combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

Detailed description

Chronic lymphocytic leukemia (CLL) and small B-cell lymphocytic lymphoma (SLL) are thought to be different manifestations of the same disease. Treatment options for CLL/SLL range from a watch and wait approach to bone marrow transplant. Currently there is no consensus on the best treatment regimen and new approaches to treatment are needed. EL625 is a 20-mer antisense molecule which binds to a coding region of exon 10 in p53 RNA transcripts. It can bind to both mutant and wild type p53. p53 is involved in regulating apoptosis and DNA repair in cells. When genetic damage occurs p53 is upregulated. As the expression of p53 increases in normal cells they are more likely to undergo apoptosis rather than cell cycle arrest and DNA repair. However in malignant cells, for a given level of DNA damage they are more likely to undergo cell cycle arrest and repair rather than apoptosis. Because EL625 is theorized to increase response to chemotherapy, we propose adding EL625 to a combination of fludarabine, cyclophosphamide and rituximab.

Conditions

• Lymphoma, Small Lymphocytic
• Leukemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
DRUG	cenersen sodium	2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4
DRUG	Rituximab	375 mg/m2 on day 2
DRUG	Cyclophosphamide	250 mg/m2 on days 2, 3, and 4
DRUG	Fludarabine	25 mg/m2 on days 2, 3, and 4

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-08-01
• Completion: 2012-05-01
• First posted: 2008-03-14
• Last updated: 2012-11-28
• Results posted: 2012-08-22

Locations

1 site across 1 country: United States