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Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

ConditionsAcute Lymphoblastic LeukemiaLymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSt. Jude Children's Research Hospital

About this trial

This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma.

Primary Objective

* To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131.

Secondary Objectives

* To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Enrollment on INITIALL.

Age 1-18.99 years at the time of enrollment on INITIALL.

B-Acute lymphoblastic leukemia or lymphoblastic lymphoma.

No prior chemotherapy excluding therapy given on or allowed by INITIALL.

Disqualifiers

Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy.

History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation.

Active uncontrolled infection.

Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dexamethasone

    Drug

    Given orally (PO) or intravenously (IV).

  • Vincristine

    Drug

    Given IV.

  • Inotuzumab

    Drug

    Given IV.

  • Blinatumomab

    Drug

    Given IV.

  • Dasatinib

    Drug

    Given PO.

  • IT MHA

    Procedure/Surgery

    Given Intrathecal (IT), Age adjusted.

  • Cyclophosphamide

    Drug

    Given IV.

  • Cytarabine

    Drug

    Given IV or IT.

  • Methotrexate

    Drug

    Given IT, IV, PO or intramuscular (IM).

  • 6-Mercaptopurine

    Drug

    Given PO.

  • Calaspargase

    Drug

    Given IV.

  • Daunorubicin

    Drug

    Given IV.

  • Thioguanine

    Drug

    Given PO (participants intolerant to mercaptopurine).

Treatment groups

128 Participants
are divided into 1 treatment group
Group A: SJALL23H Treated PatientsExperimental treatment 13 interventions

Trial outcomes

Primary outcomes

1

End of induction minimal residual disease negative remission

Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint.

Time frame
On treatment to end of induction, approximately 29 days

Secondary outcomes

1

Comparison of MRD-negative rates to those on Total 17

Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease will be compared between patients enrolled on this trial and patients with similar clinical features (age, WBC at diagnosis, CNS status, testicular involvement) enrolled on Total 17(NCT03117751).

Time frame
On treatment to end of induction, approximately 29 days
2

Compare significant toxicities experienced to those on Total 17

We will compare CTCAE version 5 clinically significant, non-hematological grade 3 or any non-hematological grade 4-5 toxicities. This comparison will encompass 3 periods: induction/ consolidation, reinduction, and reconsolidation.

Time frame
On treatment to end of reconsolidation, approximately 56 days.
3

Event free survival (EFS)

Kaplan-Meier estimates of the survival functions for event-free survival (EFS) will be calculated along with standard error. For EFS, death due to any cause, any relapse, consolidation failure, and second malignancy are considered as failure; patients remaining failure-free at the last follow up are censored.

Time frame
3.5 years after enrollment.
4

Overall survival (OS)

Kaplan-Meier estimates of the survival functions for overall survival (OS) will be calculated along with standard error. For OS, only death due to any cause is considered as failure and patients still alive at the last follow up are censored.

Time frame
3.5 years after enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Jude Children's Research Hospital

Lead sponsor

Pfizer

Collaborator

Amgen

Collaborator

Source ClinicalTrials.gov
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