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Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

PHASE3RECRUITING

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.

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Study details:

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 top of the standard treatment backbone after induction therapy. Medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo 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 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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.
  • ≤365 days of age at time of diagnosis of ALL
  • Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

    • Exclusion criteria

  • KMT2A-germline patients
  • T-ALL
  • Age > 365 days at the time of diagnosis
  • 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.
  • CD19 negative B-precursor ALL at diagnosis
  • 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).
  • Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
  • 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.
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    Eligibility

    Age eligible for study : 1 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-12-15

    Primary completion: 2027-09-01

    Study completion finish: 2030-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05327894

    Intervention or treatment

    DRUG: Blinatumomab

    DRUG: Blinatumomab

    Conditions

    • • Acute Lymphoblastic Leukemia
    • • Mixed Phenotype Acute Leukemia
    Image related to Acute Lymphoblastic Leukemia

    • Condition: Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia

    • DRUG: Blinatumomab and other drugs

    • Perth, Not Specified, Australia and more

    • Sponsor: Princess Maxima Center for Pediatric Oncology

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Perth Children's Hospital

    Research sites nearby

    Select from list below to view details:

    • Perth Children's Hospital

      Perth, Not Specified, Australia

    • Queensland Children's Hospital

      South Brisbane, Not Specified, Australia

    • Australian and New Zealand Children's Haematology/Oncology Group

      Clayton, Victoria, Australia

    • North Adelaide- Womens and Childrens Hospital

      Adelaide, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    OTHER: Medium Risk (MR)
    • Subject is defined as MR if \> 6months of age at diagnosis, OR \< 6 months of age with White Blood cell Count (WBC) \< 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is \>0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or \< 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).
    DRUG: Blinatumomab
    • 1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.
    OTHER: High risk (HR)
    • Subject is defined as HR if \< 6 months of age with WBC \> 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD ≥ 1%, or MRD \> 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab.
    • Thereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.
    DRUG: Blinatumomab
    • 1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Event free survival (EFS).The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.5 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Overall survivalThe endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.8 years
    Endpoints by risk groupThe endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.8 years
    Outcome for the entire study cohort and according to risk groupOutcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.8 years
    Minimal Residual DiseaseMRD response as defined in the protocol and frequencies of MRD levels8 years
    CD19 (cluster of differentiation antigen 19) negative relapseProportion of CD19 negative relapses in the entire study cohort and according to risk group8 years
    Myeloid lineage switchesProportion of myeloid lineage switches in the entire study cohort and according to risk group8 years
    Grade ≥3 adverse eventProportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases.8 years
    Grade ≥2 cardiac disordersProportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis5 years
    Overall survival after 1st relapseOverall survival (OS) after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group8 years

    Frequently Asked Questions

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    You may be eligible to participate in this trial based on your search.Apply for study
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    References

    Clinical Trials Gov: Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

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