NCT00083473

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

August 30, 2005

Status Verified

August 1, 2005

First QC Date

May 24, 2004

Last Update Submit

August 26, 2005

Conditions

Leukemia, Lymphocytic, ChronicLymphoma, Small Lymphocytic

Keywords

Leukemia Lymphocytic Chronic,Pivanex,Histone deacetylase inhibitor

Interventions

PivanexDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) based upon the Revised NCI-sponsored Working Group guidelines for CLL;
  • Relapsed or refractory disease after previous chemotherapy treatment;
  • Age \> 18 years;
  • Adequate renal function with creatinine \<= 1.5 mg/dL;
  • Adequate liver function with alkaline phosphatase \<= 2.5 X upper limit of normal, serum glutamic oxaloacetic transaminase (SGOT), and serum glutamic pyruvic transaminase (SGPT) \<= 2.5 X upper limit of normal; and total bilirubin \<= 2.0 X upper limit of normal;
  • Adequate bone marrow function as determined by having platelets \> 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (ANC) =\> 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
  • Able to give informed consent;
  • A minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin C, 12 weeks if radioimmunotherapy) to treatment on Day 1 Cycle 1. Patients must have recovery from treatment-associated toxicity(ies);
  • A predicted life expectancy of at least 6 months; and
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

You may not qualify if:

  • More than three systemic treatment regimens for CLL/SLL (excluding immunotherapies and biologic therapies);
  • Concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
  • Any pregnant or lactating females. Females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
  • Known HIV-positive patients;
  • Any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
  • Receiving investigational agents within 4 weeks of the study treatment; and
  • Known allergy to reagents in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Lymphoma and Myeloma; Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, B-Cell

Interventions

pivalyloxymethyl butyrate

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2004

First Posted

May 26, 2004

Study Start

May 1, 2004

Study Completion

April 1, 2005

Last Updated

August 30, 2005

Record last verified: 2005-08

Locations

US(1)