Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Summary

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Conditions

• Adult T Acute Lymphoblastic Leukemia
• Ann Arbor Stage II Adult Lymphoblastic Lymphoma
• Ann Arbor Stage II Childhood Lymphoblastic Lymphoma
• Ann Arbor Stage III Adult Lymphoblastic Lymphoma
• Ann Arbor Stage III Childhood Lymphoblastic Lymphoma
• Ann Arbor Stage IV Adult Lymphoblastic Lymphoma
• Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma
• Childhood T Acute Lymphoblastic Leukemia

Interventions

DRUG

Bortezomib

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, IV, or SC

DRUG

Daunorubicin

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

DRUG

Ifosfamide

Given IV

DRUG

Leucovorin Calcium

Given PO or IV

DRUG

Mercaptopurine

Give PO

DRUG

Methotrexate

Given IT, IV, or PO

DRUG

Pegaspargase

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Thioguanine

Given PO

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• David T Teachey · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-04

Primary Completion

2020-03-31

Completion

2026-09-16

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations