International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia
- Conditions
- 10024324Leukemiaacute lymphoblastics leukemia (ALL)
- Registration Number
- NL-OMON51982
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL according to
the WHO classification of tumours of haematopoietic and lymphoid tissues
(revised 4th edition 2017, with KMT2A-rearrangement.
2. <= 365 days of age at the time of diagnosis of ALL.
3. Written informed consent of the parents or other legally authorized
guardian of the patient according to local law and regulations.
1. KMT2A-germline patients.
2. T-ALL.
3. Age > 365 days at the time of diagnosis.
4. Relapsed ALL.
5. 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.
Additional exclusion criteria for blinatumomab:
1. CD19 negative B-precursor ALL at diagnosis
2. CNS involvement (CNS2/CNS3/TLP+ status) at the EOI. Patients with CNS
disease at the time of diagnosis are eligible if CNS1 status is achieved prior
to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of
induction).
3. Proven hypersensitivity to the active substance or any of the excipients in
blinatumomab.
4. Patients who have received a live vaccine 28 days prior to blinatumomab
administration or plan to receive a live vaccine prior to B-cell recovery after
the last dose of blinatumomab.
If exclusion criteria for blinatumomab are met, the patient should be treated
according to the protocol but without blinatumomab.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is Event Free Survival, defined as the time from diagnosis<br /><br>to resistance to induction, relapse, death from any cause or second malignancy<br /><br>(whichever occurs first), or time to last follow-up (censored) for patients<br /><br>without events.</p><br>
- Secondary Outcome Measures
Name Time Method