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First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL

NCT01004497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-05-29

No results posted yet for this study

Summary

The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Dasatinib

After the completion of each induction and consolidation chemotherapy with recovery of leukocyte and platelet counts, dasatinib will be given as an alternative manner: 100 mg by mouth once daily for 4 weeks

DRUG

Cyclophosphamide

300 mg/m2, IV for 2 hours, every 12 hours x 6 doses, days 1-3

DRUG

Vincristine

1.4 mg/m2/day (maximum 2 mg/day), IV for 30 minutes, days 4 \& 11

DRUG

Daunorubicin

45 mg/m2/day, IV for 1 hour, days 4 \& 11

DRUG

Dexamethasone

40 mg/day, IV push, days 1-4 \& days 11-14

DRUG

Cytarabine

2 g/m2, IV for 3 hours, every 12 hours x 10 doses, days 1-5

DRUG

Mitoxantrone

12 mg/m2/day, IV for 30 minutes, days 1-2

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Seok Lee, M.D. · Catholic BMT Center, Seoul St. Mary's Hospital, The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-04-30
Completion
2015-04-30

Countries

  • South Korea

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 NCT01004497 on ClinicalTrials.gov