Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Summary

This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, 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. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.

Conditions

• Acute Undifferentiated Leukemia
• B-cell Adult Acute Lymphoblastic Leukemia
• B-cell Childhood Acute Lymphoblastic Leukemia
• L1 Adult Acute Lymphoblastic Leukemia
• L1 Childhood Acute Lymphoblastic Leukemia
• L2 Adult Acute Lymphoblastic Leukemia
• L2 Childhood Acute Lymphoblastic Leukemia
• Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia
• Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
• Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia
• T-cell Adult Acute Lymphoblastic Leukemia
• T-cell Childhood Acute Lymphoblastic Leukemia
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

allopurinol

Given PO

DRUG

cyclophosphamide

Given IV

DRUG

daunorubicin hydrochloride

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

dexamethasone

Given PO and as eye drops

DRUG

asparaginase

Given SC

BIOLOGICAL

filgrastim

Given SC

DRUG

imatinib mesylate

Given PO

DRUG

methotrexate

Given IT, IV, and PO

DRUG

cytarabine

Given IV

DRUG

trimethoprim-sulfamethoxazole

Given PO

DRUG

mercaptopurine

Given PO

DRUG

leucovorin calcium

Given IV and PO

BIOLOGICAL

alemtuzumab

Given SC

DRUG

acyclovir

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Wendy Stock · Cancer and Leukemia Group B

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2007-12-31

Completion

2012-10-31

Countries

• United States

Study Locations