Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

Sponsor
Children's Oncology Group
Study ID
NCT07072585
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Stage II T Lymphoblastic Leukemia/Lymphoma
  • Stage III T Lymphoblastic Leukemia/Lymphoma
  • Stage IV T Lymphoblastic Leukemia/Lymphoma
  • T Acute Lymphoblastic Leukemia
  • T Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
365 Days - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Bortezomib — DRUG
    Given IV or SC
  • Calaspargase Pegol — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT or IV or SC
  • Daratumumab — BIOLOGICAL
    Given IV
  • Daunorubicin Hydrochloride — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO or IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Lumbar Puncture — PROCEDURE
    Under lumbar puncture
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Mercaptopurine Oral Suspension — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT or IV or PO
  • Methylprednisolone — DRUG
    Given IV
  • Nelarabine — DRUG
    Given IV
  • Pegaspargase — DRUG
    Given IV or IM
  • Positron Emission Tomography — PROCEDURE
    Undergo PET or PET-CT
  • Prednisolone — DRUG
    Given PO or IV
  • Prednisone — DRUG
    Given PO or IV
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Therapeutic Hydrocortisone — DRUG
    Given IT
  • Thioguanine — DRUG
    Given PO
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Key Dates

Start date
Aug 28, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2035
Completion
Sep 1, 2035

Study Design

Enrollment
1,708 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group I, Arm A (T-ALL, no daratumumab)
    See Detailed Description
  • Experimental: Group I, Arm B (T-ALL, daratumumab)
    See Detailed Description
  • Active Comparator: Group II, Arm C (T-LL, no daratumumab)
    See Detailed Description
  • Experimental: Group II, Arm D (T-LL, daratumumab)
    See Detailed Description

Primary Outcome Measure

Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL) [ Time Frame: From date of randomization (randomization conducted at the end of induction [EOI]) to date of first event (consolidation failure, interim maintenance failure, relapse, secondary malignant neoplasm [SMN], death from any cause), assessed up to 4 years ]

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