Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
About this study
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
- Condition
- Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- Tested
- Blinatumomab, Blinatumomab
- Sponsor
- Princess Maxima Center for Pediatric Oncology
Who can join
- Age
- 0 to 1 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 0 years
- Maximum age: 1 years
- Study condition: Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
Exclusion 8
- KMT2A-wildtype patients.
- Multilineage MPAL
- T-ALL.
- Age \> 365 days at the time of diagnosis.
- Down syndrome.
- Relapsed ALL.
- Treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
- If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
Where
124 sites, 92 recruiting
North Adelaide- Womens and Childrens Hospital
Adelaide, Australia
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Victoria, Australia
New Lambton Heights- John Hunter Children's Hospital
New Lambton Heights, Australia
Perth Children's Hospital
Perth, Australia
Sydney Childrens Hospital
Sydney, Australia
The Childrens Hospital at Westmead
Westmead, Australia
and 118 more sites on ClinicalTrials.gov
Contact
-
Lieke van den Wildenberg
0031 88 972 72 72 trialmanagement@prinsesmaximacentrum.nl
-
Peggy Scholte-Van Houtem
0031 88 972 72 72 trialmanagement@prinsesmaximacentrum.nl
Potential match only. Final eligibility is determined by the study team.