MedTrace Logo

Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)

NCT00909168 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-05-06

No results posted yet for this study

Summary

This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

Trial is based on:

* INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
* CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)
* INTENSIFICATION: Allo-BMT, ASCT
* MAINTENANCE: AraC

a) Primary endpoints:
* Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
* RFS, DFS and OS.

b) Secondary endpoints:
* Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
* Evaluation of prognostic clinical relevance of biological features at onset.
* Feasibility and outcome of consolidation with BMT.

Conditions

Interventions

DRUG

FLAIMy - Fluda, Ida, Ara-C, Mylotarg

FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5 ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5 IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5 GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6

Sponsors & Collaborators

  • University Hospital, Udine, Italy

    lead OTHER

Principal Investigators

  • ANNA CANDONI, MD · UUNIVERSITY HOSPITAL, UDINE, ITALY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-05-31
Completion
2013-03-31

Countries

  • Italy

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 NCT00909168 on ClinicalTrials.gov