EUCTR2010-019983-35-BEActive, not recruitingPhase 1
Phase I-II study of low dose CdA combined with valproic acid (VPA) in previously treated B-cell chronic lymphocytic leukemia (CLL) patients. - VPA-CdA in C
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •B-CLL, as defined by the NCIWG criteria
- •Patients must have intermediate or high-risk categories of the modified 3-stage Rai and Binet stagings
- •Patient MUST have progressive or symptomatic disease as defined by any of the following conditions:
- •- Progressive lymphocytosis with a lymphocyte count increased > 50% over the last 2 month period or an anticipation of the doubling time in less than 6 months
- •- Progressive or symptomatic splenomegaly or hepatomegaly
- •- Progressive or symptomatic lymphadenopathy
- •- Evidence of progressive marrow failure as manifested by development or worsening of anemia and/or thrombocytopenia
- •- Presence of any B-symptoms: weight loss = 10% within the previous 6 months, fever > 38.0°C for = 2 weeks without evidence of infection, or night sweats without evidence of infection.
- •Patient must have received one or more prior therapies for CLL. Patients may have received any of the following prior treatment regimens: fludarabine-containing combinations, alemtuzumab single agent or combination, rituximab combinations, chlorambucil, cyclophosphamide +/- prednisone, CVP, or other forms of immunotherapy…
- •Patients must have adequate organ function:
- •Neutrophils > 500/mm³
- •Platelets > 50.000/mm³
- •Creatinine clearance (measured or calculated) > or = 40 ml/min
- •Age > 18 years
- •Patient’s ECOG performance status must be 0-2
- •Patient’s written informed consent
- •Life expectancy > 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patients having received VPA within 3 months
- •Previous, suspected or known hypersensitivity to VPA, or any of its derivatives
- •Liver porphyria
- •Epilepsy due to mitochondrial diseases
- •Ongoing treatment with VPA-interacting drugs
- •CIRS (Cumulative Illness rating Scale) > 6
- •Prior allogenic or autologous bone marrow transplantation less than 12 months
- •Patient having received any anticancer agents (chemotherapy, immunotherapy or targeted agents) within 4 weeks
- •CNS involvement
- •Concomitant disease requiring prolonged use of corticosteroids (> 1 month)
- •Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma)
- •Creatinine clearance < 40 ml/min calculated according to the formula of Cockcroft and Gault. Patients with a calculated creatinine clearance below 40 ml/min may be eligible if (1) a measured creatinine clearance (based on 24-h urine collection or other reliable method) is > 40 ml/min, or (2) a new calculation conducted after adequate hydration is > 40 ml/min.
- •Any coexisting medical or psychological condition that would preclude participation to the required study procedures
- •Patient with mental deficiency preventing proper understanding of the requirements of treatment
- •Pregnancy, lactating woman, females of childbearing potential or male patient who are unwilling to use adequate contraception
- •Clinically significant auto-immune cytopenia, Coombs-positive hemolytic anemia as judged by the treating physician
- •Patients with a history of another malignancy in complete remission less than 2 years, except basal cell skin cancer, stage 0 (in situ) cervical carcinoma or tumor treated curatively by surgery.
- •Any severe co-morbidities such as NYHA Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, or severe uncontrolled myocardiopathy, uncontrolled hypertension, severe chronic obstructive pulmonary disease with hypoxemia or uncontrolled diabetes mellitus.
- •Active bacterial, viral or fungal infection
- •Seropositivity for: HIV, hepatitis C or hepatitis B (unless clearly due to vaccination)
- •Liver insufficiency
- •Total bilirubin > 2 x the upper limit of normal (ULN)
- •Prior history of severe hepatic or pancreatic disorder
- •Alkaline phosphatases and aminotransferases (AST, ALT) > 2 x ULN
Investigators
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