Clinical Trials Logo

Clinical Trial Summary

This pilot study will assess the safety and efficacy of Pivanex alone in patients with chronic lymphocytic leukemia (CLL) who have relapsed or refractory disease after previous chemotherapy treatment. Pivanex is an investigational agent.


Clinical Trial Description

Rationale: Chronic lymphocytic leukemia (CLL) is a disease characterized by the accumulation of mature lymphocytes. These CLL lymphocytes are blocked from undergoing terminal differentiation and apoptosis. Patients with CLL have limited options for therapy, especially after the failure of standard chemotherapy regimens. Histone deacetylase inhibitors (HDACs) comprise a new class of drugs being evaluated in the treatment of various malignancies. In vitro data suggest that HDAC inhibition leads to terminal B-cell differentiation and may therefore play a therapeutic role in the treatment of CLL. Pivanex (pivaloyloxymethyl butyrate) is an HDAC inhibitor that has been shown to induce apoptosis of CLL lymphocytes in vitro. In previous clinical trials, Pivanex has been well tolerated. The goal of this protocol is to determine the effects of Pivanex in patients with CLL.

Purpose: This open-label trial will determine the response rate of Pivanex in patients with CLL.

Objectives: (1) Determine the response rate of Pivanex in patients with relapsed CLL; (2) Determine time to disease progression in patients with relapsed CLL treated with Pivanex; and (3) Determine the safety profile of Pivanex in CLL.

Design: This is an open label, single arm, multiple dose, pilot study of patients with relapsed CLL. Patients will be treated with 2.5 g/m2 of Pivanex administered intravenously over 6 hours daily on Days 1 – 3. Treatment will be repeated every 21 days until disease progression or the patient is withdrawn from treatment for protocol-specified reasons.

Disease status will be assessed prior to every odd-numbered treatment cycle using response criteria based upon the Revised National Cancer Institute-sponsored Working Group Guidelines for CLL. Patients withdrawn due to disease progression will be followed for survival. Patients withdrawn from study for reasons other than disease progression will be followed for disease progression and survival. ;


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


NCT number NCT00083473
Study type Interventional
Source Titan Pharmaceuticals
Contact
Status Terminated
Phase Phase 2
Start date May 2004
Completion date April 2005

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
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
Completed NCT00535912 - Phase III Study Treatment of CLL B and C Phase 3