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Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT01005914 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-01-06

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving pegaspargase together with combination chemotherapy and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

Interventions

DRUG

cyclophosphamide

Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3

DRUG

cytarabine

Day 2 \& 3: 3g/m2 IV over 2 hours q12 X 4

DRUG

dexamethasone

Day 1-4; 11-14: 40 mg daily

DRUG

doxorubicin hydrochloride

Day 4: 50 mg/m2 IV over 2 hours

DRUG

imatinib mesylate

600 mg/day

DRUG

methotrexate

Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion

DRUG

methylprednisolone

Day 1-3: 50mg IV BID

DRUG

pegaspargase

Day 3/Day4: 2,500 IU/ m2 IV

DRUG

vincristine sulfate

Day 4 \& 11: 2 mg IV

Sponsors & Collaborators

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Brandon Hayes-Lattin · OHSU Knight Cancer Institute

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
2009-06-30
Primary Completion
2013-03-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005914 on ClinicalTrials.gov