Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Summary

This phase II trial tests the safety and effectiveness of giving chemotherapy with or without venetoclax and/or navitoclax for the treatment of patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). 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. Venetoclax and navitoclax are in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. They may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving chemotherapy with or without venetoclax and/or navitoclax may be effective treatments for patients with newly diagnosed T-ALL or T-LBL.

Conditions

• T Acute Lymphoblastic Leukemia
• T Lymphoblastic Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Calaspargase Pegol

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, IV or SC

DRUG

Daunorubicin

Given IV

DRUG

Dexamethasone

Given PO

DRUG

Doxorubicin

Given IV

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

BIOLOGICAL

Navitoclax

Given PO

DRUG

Nelarabine

Given IV

DRUG

Pegaspargase

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

DRUG

Thioguanine

Given PO

DRUG

Venetoclax

Given PO

DRUG

Vincristine

Given IV

PROCEDURE

X-Ray Imaging

Undergo X-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kristen M O'Dwyer · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-09

Primary Completion

2026-09-22

Completion

2026-09-22

FDA Drug

Yes