Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

Summary

This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.

Conditions

• Recurrent Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

L-asparaginase

Given IM

DRUG

doxorubicin hydrochloride

Given IV

DRUG

therapeutic hydrocortisone

40 mg/m2/day PO divided BID or TID

DRUG

vincristine sulfate

Given IV

BIOLOGICAL

epratuzumab

Given IV

DRUG

cytarabine

Given IT

DRUG

prednisone

Given orally

DRUG

pegaspargase

Given IM

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

methotrexate

Given IT

DRUG

etoposide

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

leucovorin calcium

Given IV

BIOLOGICAL

filgrastim

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Elizabeth Raetz, MD · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations