E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic lynphocytic leukemia (CLL) refractory/relapsed after conventional chemotherapy or relapsed after autologous bone marrow transplantation |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008958 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Rate of complete or partial response in all patients |
|
E.2.2 | Secondary objectives of the trial |
1) Evaluate safety and tolerability
2) Rate of total responders (complete + partial responders)
3) 6 months progression free survival
4) Evaluate ITF2357 effects on ematological parameters |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
ユ Confirmed diagnosis of CLL according to the NCI Working Group criteria.
ユ Male and female patients of age >=18 and <=75 years
ユ Patients relapsed/refractory to conventional chemotherapy (>1 polychemotherapy regimen) or relapsed after autologous bone marrow transplantation
ユ ECOG performance score of <=2
ユ Limphocytes >=10.0x109/l and platelets >100.0x109/l after recovery from a previous therapy
ユ Percentage of CD9+/CD5+ leukemic cells >50%
ユ Adequate cardiac, pulmonary and renal function, as defined by LVEF >45%, FEV >50% and creatinine <=1.5 ULN or creatinine clearance >=50ml/min
ユ Serum bilirubine <1.5xULN, AST and ALT <2.5xULN
ユ Serum potassium, phosphorus, total calcium, magnesium >LLN
ユ Normal values for FT4 and TSH (patients may be on thyroid hormone replacement)
ユ Negative test for beta-HCG for women in fertile age, or breast feeding women.
ユ Documentation of written informed consent to participate in the trial
ユ Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. |
|
E.4 | Principal exclusion criteria |
ユ Patients with Autoimmune haemolytic anaemia, Autoimmune Thrombocytopenic Purpura and Fischer Evans Syndrome .
ユ Patients with other autoimmune diseases.
ユ Prior treatment with an HDAC inhibitor.
ユ Treatment with Rituximab or Alemtuzumab within 90 days prior to study therapy.
ユ Patients HIV positive, or patients with active HBV and/or HCV or cirrhosis.
ユ Patients with active uncontrolled viral or bacterial or mycotic infection.
ユ Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
ユ 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.
ユ Patients in treatment with corticosteroids
ユ 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.
ユ Uncontrolled hypertension.
ユ Malabsorption syndromes. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of complete or partial response in all patients |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |