Suspended

Pivanex for Relapsed Chronic Lymphocytic Leukemia Treatment

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What is being tested

Data Collection

Who is being recruted

Chronic Disease+13

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

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: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

Chronic lymphocytic leukemia (CLL) is a condition where mature lymphocytes, a type of white blood cell, accumulate and do not die as they should. This results in limited therapy options, especially when standard chemotherapy treatments fail. A new class of drugs, known as histone deacetylase inhibitors (HDACs), is being explored for treating various cancers. One such HDAC inhibitor is Pivanex, which has shown promise in inducing the death of CLL lymphocytes in lab settings. This study aims to understand the effects of Pivanex in patients with CLL, potentially offering a new treatment option for this condition. This is an open-label trial, meaning everyone involved knows the treatment being used. Participants, who have relapsed CLL, will receive 2.5 g/m2 of Pivanex intravenously over 6 hours daily for three days. This treatment cycle will repeat every 21 days until the disease progresses or the patient is withdrawn for specific reasons outlined in the study protocol. The study will measure the response rate to Pivanex, time to disease progression, and the safety profile of the drug in CLL patients. Disease status will be assessed before every odd-numbered treatment cycle using established CLL guidelines.

Official TitleA Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Chronic Lymphocytic Leukemia
Principal SponsorTitan Pharmaceuticals
Last updated: January 27, 2026
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 enrolled

Total 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.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes

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;

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);

Relapsed or refractory disease after previous chemotherapy treatment;

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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 University

New York, United StatesOpen Center for Lymphoma and Myeloma; Weill Medical College of Cornell University in Google Maps
SuspendedOne Study Center