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Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

NCT00890656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-02-20

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this therapy will also be studied.

Conditions

Interventions

DRUG

Cyclophosphamide (CTX)

300 mg/m\^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of

DRUG

Vincristine

2 mg by vein (IV) weekly for 3: Days 1, 8, 15

DRUG

Doxorubicin

50 mg/m\^2 by vein (IV) over 24 hours

DRUG

Decadron

80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18

DRUG

G-CSF

10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours

DRUG

Methotrexate (MTX)

200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1

DRUG

Ara-C

3 gm/m\^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.

DRUG

Pegaspargase

2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses

Sponsors & Collaborators

  • Enzon Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Stefan F. Faderl, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00890656 on ClinicalTrials.gov