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Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

NCT00671658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-12-03

Study results available
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Summary

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

Conditions

Interventions

DRUG

Rituximab

375 mg/m2 by vein

DRUG

Cyclophosphamide (CTX)

300 mg/m2 by vein

DRUG

Doxorubicin

50 mg/m2 by vein

DRUG

Vincristine

2 mg by vein

DRUG

Dexamethasone

40 mg by vein or by mouth (P.O.)

DRUG

Methotrexate (MTX)

12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8

DRUG

Cytarabine

100 mg intrathecal for Courses 1,3,5,7 3 gm/m2 by vein for Courses 2,4,6,8

DRUG

G-CSF

10 ug/kg subcutaneous injection

DRUG

Mesna

600 mg/m2 a day by vein

DRUG

Pegylated asparaginase

2000 International units/m2 by vein

DRUG

Pegfilgrastim

6 mg (flat dose) within 72 hrs after completion of chemotherapy

DRUG

Solumedrol

40 mg by vein for Courses 2,4,6,8

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Susan O'Brien, 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
2002-11-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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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 NCT00671658 on ClinicalTrials.gov