phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients

NCT00496431 | Terminated Phase 1 DMC

• 2 other identifiers: DSC/07/2357/262007-000049-36
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

PRIMARY OBJECTIVE \- To evaluate the efficacy (according to the International Working Group response criteria for Hodgkin's Lymphomas \[7, 8, 9\]) of daily oral doses of ITF2357 administered to very high-risk Hodgkin's lymphoma patients. SECONDARY OBJECTIVES

• To evaluate safety and tolerability of multiple oral doses of ITF2357
• To assess the proportion of patients that, after ITF2357 treatment, can undergo high-dose salvage chemotherapy with either autografting or allografting

Conditions

Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Total number of Objective Responses (OR): Complete Responses (CR) and Partial Responses (PR)

  The objective response of the patients was assessed as complete response or partial response after ITF2357 treatment.

  every 28 days

Secondary Outcomes (1)

• Number of subjects experiencing an Adverse Events

  Throughout the study till follow-up after 3 months

Study Arms (1)

ITF2357

EXPERIMENTAL

Patients were provided with the appropriate number of 50 mg hard gelatine capsules for oral administration for 7 days treatment, i.e. at the daily dose of 100 mg, 14 capsules 50 mg each, plus 2 spare capsules suitable in case of accidental loss.

Drug: histone deacetylase inhibitor (ITF2357)

Interventions

histone deacetylase inhibitor (ITF2357) DRUG

50 mg b.i.d. (or every 8 hours or every 6 hours), every day

Also known as: Givinostat

ITF2357

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form; Age ≥ 18 years; History of histologically confirmed Hodgkin's lymphoma Subjects are eligible for this trial if (1) they have failed at least 1 cycle of chemotherapy, with or without radiotherapy, and if (2) they are considered incurable by the referring physician, and would be treated with second-line or subsequent-line salvage regimens, mainly with palliative intent; Clinical laboratory values ANC \> 1500/µL; Platelet count \> 75000/µL Hemoglobin \> 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level) Total bilirubin \< 1.6 mg/dL; AST or ALT \< 2.5 times the upper limit of normal Serum creatinine \< 2.0 mg/dL or creatinine clearance \> 50 mL/min Serum Potassium and Magnesium within normal limits; Measurable disease (according to the International Working Group response criteria for HL); ECOG performance status of 0 or 1; Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard); Life expectancy of \> 3 months;; At least 4 weeks since last treatment for HL Willingness and capability to comply with the requirements of the study;

You may not qualify if:

• Active bacterial or mycotic infection requiring antimicrobial treatment on Day 1; Pregnancy or lactation; A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \> 450 ms, according to Bazett's correction formula); The use of concomitant medications that prolong the QT/QTc interval;
• Clinically significant cardiovascular disease e.g.:
• Uncontrolled hypertension, myocardial infarction, unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure History of any cardiac arrhythmia requiring medication (irrespective of its severity) Grade II or greater peripheral vascular disease A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); Positive blood test for HIV, HBV and HCV; Identification of viral DNA by quantitative PCR for EBV (Ebstein Barr virus), JC virus, CMV (Cytomegalovirus) and Herpes Zoster; History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications;

Sponsors & Collaborators

• Italfarmaco: lead

Study Sites (1)

Istituto Nazionale per lo studio e la cura dei Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

givinostat hydrochloride; givinostat

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alessandro Massimo Gianni, MD

  Istituto Nazionale per lo studio e la cura dei Tumori (Milan - Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

IT (1)