Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia.

Conditions

• Adult Acute Lymphoblastic Leukemia in Remission

Interventions

DRUG

imatinib mesylate

Given PO

DRUG

methotrexate

Given IT and IV

DRUG

vincristine sulfate

Given IV

DRUG

leucovorin calcium

Given IV and PO

PROCEDURE

peripheral blood stem cell transplantation

Undergo PBSCT

PROCEDURE

autologous hematopoietic stem cell transplantation

Undergo autologous PBSCT

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic PBSCT

RADIATION

total-body irradiation

Undergo TBI

DRUG

tacrolimus

Given IV or PO

BIOLOGICAL

filgrastim

Given SC

DRUG

etoposide

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Meir Wetzler · Cancer and Leukemia Group B

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-04-30

Primary Completion

2012-04-30

Completion

2014-02-28

Countries

• United States

Study Locations