Status:
RECRUITING
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Lead Sponsor:
Princess Maxima Center for Pediatric Oncology
Collaborating Sponsors:
University of Milano Bicocca
Amgen Europe B.V
Conditions:
Acute Lymphoblastic Leukemia
Mixed Phenotype Acute Leukemia
Eligibility:
All Genders
1-1 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
All infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. All patients will receive one cycle of blinatumomab on...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 criteria for blinatumomab:
- 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.
Exclusion
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05327894
Start Date
December 15 2022
End Date
September 1 2030
Last Update
January 8 2026
Active Locations (112)
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1
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
Buenos Aires, Argentina
2
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Victoria, Australia
3
North Adelaide- Womens and Childrens Hospital
Adelaide, Australia
4
Monash Children's Hosptial
Clayton, Australia