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.
- Conditions
- Acute Lymphoblastic Leukemia (ALL)Leukemia10024324
- Registration Number
- NL-OMON49535
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8
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, 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 Interfant06 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.
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 in the protocol); 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 x109/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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of clinically relevant toxicities defined as any toxicity that is<br /><br>possibly or definitely attributable to blinatumomab AND results in permanent<br /><br>discontinuation of blinatumomab OR death. </p><br>
- Secondary Outcome Measures
Name Time Method