MedTrace Logo

Dasatinib (Sprycel™) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

NCT00850382 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2016-03-01

No results posted yet for this study

Summary

This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in a one-year maintenance therapy in patients with newly diagnosed CBF AML.

82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers.

All AML patients will be assessed for the CBF fusion genes via the central laboratory of the AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled into the study.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Dasatinib

Induction cycle(s): Dasatinib 100 mg QD on days 8-21. Consolidation Cycles 1, 2, 3, 4: Patients will receive dasatinib 100 mg QD on days 6-28. Maintenance therapy: Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse).

DRUG

daunorubicin

Induction cycle(s): Daunorubicin 60 mg/m2/day administered on days 1 through 3

DRUG

Cytarabine

Induction cycle(s): Cytarabine 200 mg/m2/day administered by continuous IV infusion daily for 7 days (days 1 through 7). Consolidation cycles 1, 2, 3, 4: Consolidation therapy consists of high-dose cytarabine 3 g/m2 (\>60 years: 1 g/m2) q12h, d 1, 3, 5, administered intravenously over three hours.

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Hartmut Doehner, MD · University Hospital of Ulm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT00850382 on ClinicalTrials.gov