Bortezomib trial for the treatment of childhood relapsed acute lymphoblastic leukemia

• Conditions: acute lymphoblastic leukemia; MedDRA version: 16.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-014037-25-AT
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-02
• Last Update Posted: 16 November 2015

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: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 2
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.;Timepoint(s) of evaluation of this end point: Day 8