Clinical Trials Logo

Clinical Trial 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)


Clinical Trial 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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00636155
Study type Interventional
Source Duke University
Contact
Status Terminated
Phase Phase 2
Start date February 2008
Completion date May 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03204188 - Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Phase 2
Completed NCT02758665 - Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL Phase 2
Terminated NCT00393380 - Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor Phase 2
Terminated NCT00176930 - Stem Cell Transplant for Hematological Malignancy N/A
Completed NCT00562224 - Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients Phase 1
Completed NCT00186303 - Transplantation for Patients With Chronic Lymphocytic Leukemia N/A
Completed NCT00270049 - Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia Phase 2
Terminated NCT02440685 - A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT00083473 - A Pilot Study of Pivanex in Patients With Chronic Lymphocytic Leukemia Phase 2
Completed NCT04030195 - Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL Phase 1/Phase 2
Completed NCT00464633 - Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL) Phase 2
Terminated NCT00290407 - Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL) Phase 2
Completed NCT00055146 - Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Phase 2
Not yet recruiting NCT05154474 - Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy
Completed NCT00289549 - Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL) Phase 2
Terminated NCT01045382 - MSC and HSC Coinfusion in Mismatched Minitransplants Phase 2
Terminated NCT01050946 - Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit Phase 2
Completed NCT00283101 - A Safety Study in Patients With Chronic Lymphocytic Leukemia Phase 1/Phase 2
Completed NCT00546793 - Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL Phase 1/Phase 2
Terminated NCT00167180 - Post Transplant Donor Lymphocyte Infusion Phase 2