Blinatumomab in infant A

Phase 1

• Conditions: Acute Lymphoblastic Leukemia; MedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004674-17-NL
• Lead Sponsor: Princess Máxima Center for Pediatric Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients must be treated according to Interfant-06 backbone
2.Patients must have newly diagnosed, CD19 positive, B-precursor acute lymphoblastic leukemia
3.Morphological verification of the diagnosis, confirmed with immunophenotyping
4.= 365 days of age at time of diagnosis of ALL
5.> 28 days of age at start of blinatumomab administration
6.MR and HR patients according to risk stratification of the Interfant-06 protocol (see table 1), thus including all MLL-rearranged and MLL not-evaluable patients (these latter are stratified and treated according to MR).
7.M1 or M2 bone marrow after induction (~day 33).
If the peripheral blood shows pancytopenia at day 33 it is justified to postpone the bone marrow puncture according to the Interfant-06 protocol. If the bone marrow at day 33 is hypocellular and one is therefore unable to determine M1 or M2 status, then the bone marrow puncture should be repeated.
8.Written informed consent from parents or guardians

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

1.Biphenotypic ALL
2.Mature B-ALL
3.Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript
4.M3 marrow after induction
5.Patients with Down syndrome (because of increased toxicity of conventional chemotherapy)
6.Clinically relevant CNS pathology requiring treatment (eg unstable epilepsy)
7.Evidence of CNS involvement of ALL (CNS2 or CNS3) at the end of induction. Subjects with CNS disease at the time of diagnosis are eligible if a CNS1 status is obtained prior to enrolment (lumbar puncture at ~day 29 of induction, see definitions CNS status in Appendix D)
8.Known infection with human immunodeficiency virus (HIV)
9.Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing

Exclusion criteria before start (-d3) of blinatumomab:
1.Peripheral neutrophils <0.5 x 109/l and WBC <2 109/l (for M1 marrow only, with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
2.Peripheral platelets < 50 x 109/L (for M1 marrow only with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
3.Creatinine > 1.5 X ULN, based on the normal ranges for age and gender of the local laboratories
4.Total bilirubin > 3 x ULN unless the patient has documented Gilbert Syndrome
5.Chemotherapy related toxicities that have not resolved to = grade 2
6.Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified