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

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06533748
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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).

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2034

Study Design

Enrollment
128 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SJALL23H Treated Patients
    All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Cyclophosphamide, Dasatinib, IT MHA. Early Post Induction: Cyclophosphamide, Cytarabine, Inotuzumab, Methotrexate, IT MHA, Dasatinib, Blinatumomab, 6-mercaptopurine, Dexamethasone, Vincristine, Daunorubicin, Calaspargase. Maintenance: Dexamethasone, Vincristine, Methotrexate, 6-mercaptopurine, Thioguanine, Dasatinib, IT MHA.

Primary Outcome Measure

End of induction minimal residual disease negative remission [ Time Frame: On treatment to end of induction, approximately 29 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Saint Francis Children's HospitalTulsaOklahoma74136
Ashraf Mohamed, MD
[email protected]
918-502-6720
Ashraf Mohamed, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Seth E. Karol, MD, MSCI
[email protected]
888-226-4343
Seth E. Karol, MD, MSCI (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tulsa, OK

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By research site
Saint Francis Children's Hospital· Tulsa, OKSt. Jude Children's Research Hospital· Memphis, TN

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