Blinatumomab in infant acute lymphoblastic leukemia (ALL)
A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.
Princess Máxima Center for Pediatric Oncology
30 participants
Jul 30, 2018
Interventional
Conditions
Summary
The purpose of this study is to assess the safety of one course of a chemotherapy drug named blinatumomab when added to the Interfant-06 backbone in infants with newly diagnosed acute lymphoblastic leukaemia. Who is it for? Your infant may be eligible if they are less than 12 months of age and have been dignosed with acute lymphoblastic leukemia. Study details All participants in this study will receive the chemotherapy drug blinatumomab every day for 4 weeks via a needle in the arm. Some of the tests required for this study are routinely performed as part of standard treatment in children with Infant ALL, such as the bone marrow aspirates, lumbar punctures and most blood tests. Some additional tests and procedures are required. It is hoped that this research will help determine if blinatumomab is safe for use in infants newly diagnosed with acute lymphoblastic leukemia.
Eligibility
Inclusion Criteria13
- Patients must be treated according to Interfant-06 backbone
- Patients must have newly diagnosed, CD19 positive, B-precursor ALL
- Morphological verification of the diagnosis, confirmed with immunophenotyping
- < 365 days of age at time of diagnosis of ALL
- > 28 days of age at start of blinatumomab administration
- MR and HR patients according to risk stratification of the Interfant-06 protocol, thus including all MLL-rearranged and MLL not-evaluable patients (these latter are stratified and treated according to MR).
- 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.
- Written informed consent from parents or guardians
- Creatinine > 1.5 X ULN, based on the normal ranges for age and gender of the local laboratories
- Direct bilirubin > 3 x ULN unless the patient has documented Gilbert Syndrome
- Chemotherapy related toxicities that have not resolved to < grade 2
- 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
Exclusion Criteria9
- Biphenotypic ALL
- Mature B-ALL
- Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript
- M3 marrow after induction
- Patients with Down syndrome (because of increased toxicity of conventional chemotherapy)
- Clinically relevant CNS pathology requiring treatment (eg unstable epilepsy)
- 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)
- Known infection with human immunodeficiency virus (HIV)
- Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing
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Interventions
The patient will have been treated according to the Interfant-06 protocol where they will have received standard induction therapy. If the patient is eligible for the current study, blinatumomab will be added to standard arm (1B) of the Interfant-06 protocol. The patient will receive 1 course of blinatumomab. The blinatumomab course (15 micrograms/m2/day) consists of a 4-week continuous intravenous infusion. The patient will be closely monitored during the first 72 hours of treatment and will be admitted to the hospital preferably for the full 4 weeks of the blinatumomab infusion with a minimum admission of 7 days. Following treatment with blinatumomab, the patient wil lrecommence standard treatment according to Interfant-06 (protocol 1B).
Locations(3)
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ACTRN12620000542998