Suspended

A Pilot Study of Pivanex in Patients With Chronic Lymphocytic Leukemia

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What is being tested

Pivanex

Drug
Who is being recruted

Leukemia, Lymphocytic, Chronic

+ Lymphoma, Small Lymphocytic
Over 18 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004

See protocol details

Summary

Principal SponsorTitan Pharmaceuticals
Last updated: August 30, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

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. 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 Treatment will be repeated every 21 days until disease progression or the patient is withdrawn from treatment for protocol-specified reasons.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.

Official TitleA Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Chronic Lymphocytic Leukemia 
Principal SponsorTitan Pharmaceuticals
Last updated: August 30, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
28 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Leukemia, Lymphocytic, Chronic
Lymphoma, Small Lymphocytic
Criteria
10 inclusion criteria required to participate
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

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7 exclusion criteria prevent from participating
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

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Center for Lymphoma and Myeloma; Weill Medical College of Cornell UniversityNew York, United StatesSee the location
SuspendedOne Study Center