A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

Summary

The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.

Conditions

• Leukemia

Interventions

DRUG

Daunorubicin

In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.

DRUG

Vincristine

DRUG

Prednisone

DRUG

PEG-Asparaginase

DRUG

Methotrexate

DRUG

6-MP (6-Mercaptopurine)

DRUG

Cyclophosphamide

DRUG

Cytarabine

DRUG

Leucovorin

DRUG

Dexamethasone

OTHER

Blood draw

DEVICE

CT/PET scans

PET or CT scan every 6 months for 3 years

Sponsors & Collaborators

• Shire

  collaborator INDUSTRY

• Duke University

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Lehigh Valley Health Network

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Jae Park, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-07

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations