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Chronic Lymphocytic LeukemiaPhase 2NCT00792831

Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia

A Phase 2 study testing ITF2357 in people with Chronic Lymphocytic Leukemia, run by Italfarmaco at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary objective: To determine overall response-rate, complete response (CR) or partial response (PR) Secondary objectives: To assess the safety and tolerability of ITF2357; to assess total rate of responders (complete + partial responders); to determine the 6 months progression free survival; to determine the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
ITF2357
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteItaly
Study dates
Feb 2008to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of CLL according to the NCI Working Group criteria.
  • Male and female patients of age >18 and ≤75 years
  • Patients relapsed/refractory within 1 month after conventional chemotherapy (>1 polychemotherapy regimen) or relapsed within 3 months after autologous bone marrow transplantation
  • ECOG performance score of ≤2
  • Lymphocytes ≥10.0x10^9/L and platelets >75.0x10^9/L after recovery from a previous therapy
  • Percentage of CD19+/CD5+ leukemic cells >50%
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  • Adequate cardiac, pulmonary and renal function, as defined by LVEF >45%, FEV >50% and creatinine ≤1.5 ULN or creatinine clearance ≥50ml/min
  • Serum bilirubin <1.5xULN, AST and ALT <2.5xULN
  • Serum potassium, phosphorus, total calcium, magnesium >LLN
  • Normal values for FT4 and TSH (patients may be on thyroid hormone replacement)
  • Negative test for beta-HCG for women in fertile age
  • Documentation of written informed consent to participate in the trial
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Who cannot join

  • Patients with Autoimmune haemolytic anaemia, Autoimmune Thrombocytopenic Purpura and Fischer Evans Syndrome.
  • Patients with other autoimmune diseases.
  • Patients with a marked baseline prolongation of QTc interval (e.g. repeated demonstration of a QTc interval >450 ms).
  • Patients with history of additional risk factors for torsade de pointes (e.g. hearth failure, family history of Long QT Syndrome)
  • The use of concomitant medications with potential risk of torsade de pointes and/or that can prolong QTc interval
  • Prior treatment with an HDAC inhibitor.
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  • Treatment with Rituximab or Alemtuzumab within 90 days prior to study therapy.
  • Patients HIV positive, patients with active EBV, HBV, HCV infection or liver cirrhosis
  • Patients with active uncontrolled viral or bacterial or mycotic infection.
  • Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
  • Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration.
  • Patients in treatment with corticosteroids within 1 month before study start
  • Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
  • Uncontrolled hypertension.
  • Malabsorption syndromes.
  • Breast feeding women

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Internal Medicine and Public Health, University of Perugia

    Perugia, 06074

Other trials in Italy

About this study

Official title: Open Label, Uncontrolled, Pilot, Phase II Study of ITF2357 Administered Orally to Subjects With Chronic Lymphocytic Leukemia (CLL) Refractory/Relapsed After Conventional Chemotherapy or Relapsed After Autologous Bone Marrow Transplantation

Primary objective:

  • To determine overall response-rate, complete response (CR) or partial response (PR)

Secondary objectives:

  • To assess the safety and tolerability of ITF2357;
  • to assess total rate of responders (complete + partial responders);
  • to determine the 6 months progression free survival;
  • to determine the effects of the drug on haematological parameters.
Read the detailed description

This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a population of CLL patients relapsed after or refractory to conventional chemotherapy or relapsed after autologous bone marrow transplantation.

Patient received ITF 2357 orally at the dose of 100 mg x 2/die for three months with subsequent dose modifications if requested by the patient's conditions.

The study was prematurely discontinued due to recruitment problems. Since February 2008, date of first patient's first visit, until April 2009, date of early study discontinuation, only 3 patients were enrolled. The Sites involved in the study were 6 but only two actively recruited patients.

CLL is the most frequent type of leukemia in the western world and affects mainly elderly individuals, although about one third of patients are less than 60 years of age at diagnosis.

CLL is a heterogeneous disease characterised by a surprisingly diverse clinical course with patients that may have an overall survival time ranging from months to decades.

CLL accounts for approximately 7000 new cases and 4500 deaths per year in the US.

Chemotherapeutic treatment of CLL is largely ineffective and despite new emerging therapies, CLL still remains an incurable disease.

ITF 2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research Laboratories, provided with an established and powerful HDAC-inhibitory activity (see below for further details). It is being developed for a range of possible clinical applications both in oncohaematological conditions and in chronic inflammatory diseases. The former application is consistent with the well known antitumor pharmacological properties of HDAC-inhibitors as a family (i.e. cell-cycle arrest, pro-apoptotic and cell-differentiating effects); the latter application (chronic inflammation) is based of the demonstrated anticytokine effect of ITF 2357.

Being tested
ITF2357
Keywords
CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITF2357Drug

    Also called Givinostat

    Histone-Deacetylase Inhibitor

Study groups in NCT00792831
Study groupRoleWhat they receive
ITF2357ExperimentalITF2357 was supplied as hard gelatine capsules for oral administration at the strength of 100 or 50 mg. Patients had to receive ITF2357 100 mg x 2/die at 12-hour intervals, in fed conditions, for three consecutive months.
Receives: Drug: ITF2357

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of complete response (CR) or partial response (PR) to ITF2357 in all patients

    ITF2357 was given at 100 mg x 2/die for up to three months. A positive response was defined to be a patient experiencing a complete or partial remission.

    Complete remission (CR) Absence of lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms.

    Normal blood count: neutrophils ≥1.5x109/L, platelets >100x109/L, lymphocytes ≤4.0x109/L, Hb >11.0 g/dL (not supported by transfusion), BM biopsy: normal cellularity, lymphocytosis <30%.

    Partial remission (PR)

    ≥50% reduction in blood lymphocytes and ≥50% reduction in lymphadenophaty and/or 50% reduction in hepatomegaly and/or splenomegaly. Neutrophils ≥1.5x109/L or 50% improvement over baseline, platelets >100x109/L or 50% improvement over baseline, Hb >11.0 g/dL or 50% improvement over baseline (not supported by transfusion) It was considered PR

    • CR with nodular infiltrates at bone marrow biopsy (RPn)
    • CR with persistent anemia and thrombocytopenia therapy-related

    Measured: 13 weeks

Secondary outcomes (3)

  1. Total rate of responders (complete+partial responders)

    ITF2357 was given at 100 mg x 2/die for up to three months

    Measured: 13 weeks

  2. Six months progression free survival.

    ITF2357 was given at 100 mg x 2/die for up to three months

    Measured: Up to 6 months

  3. Number of subjects experiencing an adverse vents (AE), type, frequency, severity, timing and relatedness of AE

    ITF2357 was given at 100 mg x 2/die for up to three months

    Measured: Throughout the study till 90 days post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Why it stopped: Protocol needs complete restructuring in order to make it feasible and to complete the enrollment of 23 patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00792831
Sponsor's protocol ID
DSC/06/2357/21
Other IDs
2006-005465-19
Status last verified
Jan 2022
First submitted
14 Nov 2008
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ITF2357 in people with Chronic Lymphocytic Leukemia, run by Italfarmaco at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Protocol needs complete restructuring in order to make it feasible and to complete the enrollment of 23 patients.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete response (CR) or partial response (PR) to ITF2357 in all patients (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00792831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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