Bortezomib (Velcade®): a feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

-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
-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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-relapse not involving 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 and/or pericardial disease
-Existing 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
-alergy to boron and its metabolites
-no 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
Main Objective: Determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL;Secondary Objective: - Determine the feasibility and safety of combining bortezomib with conventional combination chemotherapy in children and adolescents with relapsed/refractory ALL<br>- 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<br>;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 Outcome Measures

Name	Time	Method

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