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Not yet recruitingLast updated: 9 April 2024

Interfant-21: This study is evaluating whether giving targeted therapy (called blinatumomab) in addition to standard treatment improves outcomes for infants under 1 year old who are diagnosed with acute lymphoblastic leukaemia with a specific, unfavourable genetic alterationInterfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Clinical summary

Summary

All eligible participants will receive one cycle of blinatumomab targeted therapy, on top of the standard treatment backbone after induction therapy. 

Medium risk patients, that respond well to the first cycle, will be treated with a second cycle of blinatumomab replacing one chemotherapy course after consolidation therapy.

If they do not respond well enough, they will be treated according to the current treatment standard. Minimal residual disease will be used to determine the response to blinatumomab. 

High risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are Minimal Residual Disease (MRD) negative (defined as < 0.01%).

Also medium risk patients with insufficient MRD response after induction or after the first cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation. 

Conditions

This trial is treating patients with newly diagnosed B-precursor acute lymphoblastic leukaemia (ALL) or B-cell mixed phenotype acute leukaemia (MPAL)

Cancer

Blood Cancers Haematological

Age

People0 - 1

Phase

III

Trial Acronym

Interfant-21

More information

Trial Identifiers

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Trial sponsor

Princess Maxima Center for Pediatric Oncology

Scientific Title

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Eligibility

Inclusion

  1. Patients with newly diagnosed B- precursor acute lymphoblastic leukemia (ALL) or B- cell mixed phenotype acute leukemia (MPAL) according to the World Health Organization (WHO) classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
  2. ≤365 days of age at 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.

Exclusion

  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 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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