Bortezomib (Velcade): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia - Bortezomib in relapsed A
- Conditions
- Childhood relapsed/refractory ALLTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2009-014037-25-IT
- Lead Sponsor
- OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 29
- Age between 6 months and 19 years - Patients with a second or subsequent relapsed ALL - Patients with first relapsed ALL after prior allogeneic stem cell transplantation in first complete remission - Patients with refractory first relapse of ALL, as defined by the ALL relapse protocol these patienst were enrolled in before - Circulating leukemic blasts of at least 100/ul peripheral blood (i.e. at least 0.1x109/l) - Patients must take adequate contraceptives when of childbearing potential - Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Relapse not involving the bone marrow - Symptomatic CNS leukemia - Active uncontrolled infection - Performance status (Lansky or Karnofsky score) of 60% or less - Life expectancy of less than 6 weeks - Existing peripheral neuropathy NCI grade 2 or higher - Presence of acute diffuse infiltrative myocardial and/or pericardial disease - Clinical signs of cardiotoxicity - Previous allogeneic stem cell transplantation within 100 days - Pregnant or breastfeeding - Other contra-indications for chemotherapy, including no recovery from previous treatment - Previous exposure to bortezomib - Other experimental or conventional antileukemic treatment within 7 days from start of bortezomib - Allergy to boron and its metabolites - Concomitant anti-leukemic therapy other than according to this protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: on day 8 of treatment;Main Objective: Determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL;Primary end point(s): Antileukemic activity of bortezomib when added to dexamethasone and vincristine and intrathecal methotrexate, as determined by the absolute peripheral blood (PB) blast count on day 8 of treatment. Morphology will be centrally reviewed.;Secondary Objective: - Determine the feasibility and safety of combining bortezomib with conventional combination chemotherapy in children and adolescents with relapsed/refractory ALL - Evaluate bortezomib levels and proteasome inhibition in cerebrospinal fluid, bone marrow and peripheral blood in patients with relapsed/refractory ALL, and assess the relationship to the efficacy and toxicity of bortezomib
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Antileukemic activity of bortezomib when added to demathasone and vincristine and intrathecal methotrexate, as determined by the absolute bone marrow (BM) blast percentage on day 8, and BM and PB analysis on day 22 of treatment, in absolute numbers and expressed as an M1, M2 or M3 marrow (<5%, 5-15%, 15% or above respectively). Morphology will be centrally reviewed.;Timepoint(s) of evaluation of this end point: blast percentage on day 8, and BM and PB analysis on day 22 of treatment