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)

Summary

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.

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

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

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Keith J August · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

365 Days

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-28

Primary Completion

2035-09-01

Completion

2035-09-01

FDA Drug

Yes