Blinatumomab in infant A
Completed
- Conditions
- <p>acute lymphoblastic leukemia (ALL) Acute lymfatische leukemie (ALL)</p>
- Registration Number
- NL-OMON24025
- Lead Sponsor
- Princess Maxima Center for Pediatric Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
1. Patients must be treated according to Interfant-06 backbone
Exclusion Criteria
A potential patient who meets any of the following criteria will be excluded from participation in this study:
1. Biphenotypic ALL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint Incidence of clinically relevant toxicities defined as any toxicity that is possibly or definitely attributable to blinatumomab AND results in permanent discontinuation of blinatumomab OR death.</p>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br>Toxicity/feasibility:<br>1. Incidence and severity of (serious) adverse events, independently to relationship with blinatumomab<br>2. Number of treatment interruptions due to toxicity occurring during blinatumomab<br>3. Proportion of patients that receive a full course (4 weeks) of blinatumomab<br>4. Incidence and severity of key safety parameters till start of maintenance and during long-term follow-up<br>Activity/Efficacy:<br>5. MRD response at the following time-points: TP2 d33 (end of induction), TPblina1 d15 (after initial 15 days of blinatumomab) and TPblina2 d29 (after the complete course of blinatumomab)<br>6. MRD response at the following time-points: TP2 d33 (end of induction) and TP4 (end of Protocol IB)<br>7. Proportion of MR patients with MRD > 5x10-4 before OCTADAD (indication for SCT)<br>8. cCR/CR and 6 months post-induction EFS and the long-term EFS and OS Pharmacokinetics:<br>9. Steady state concentration of blinatumomab (Css)</p>