NCT07072585 - 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) | Biotech Hunter

Enrollment

1,708

Participants

Timeline

Start Date

March 30, 2026

Primary Completion Date

September 1, 2035

Study Completion Date

September 1, 2035

Conditions

Stage II T Lymphoblastic Leukemia/LymphomaStage III T Lymphoblastic Leukemia/LymphomaStage IV T Lymphoblastic Leukemia/LymphomaT Acute Lymphoblastic LeukemiaT Lymphoblastic Lymphoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Bortezomib

Given IV or SC

DRUG

Calaspargase Pegol

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV or SC

BIOLOGICAL

Daratumumab

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Lumbar Puncture

Under lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mercaptopurine Oral Suspension

Given PO

DRUG

Methotrexate

Given IT or IV or PO

DRUG

Methylprednisolone

Given IV

DRUG

Nelarabine

Given IV

DRUG

Pegaspargase

Given IV or IM

PROCEDURE

Positron Emission Tomography

Undergo PET or PET-CT

DRUG

Prednisolone

Given PO or IV

DRUG

Prednisone

Given PO or IV

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Thioguanine

Given PO

PROCEDURE

Ultrasound Imaging

Undergo ultrasound

DRUG

Vincristine Sulfate

Given IV

All Listed Sponsors

lead

Children's Oncology Group

NETWORK