Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML) (MYFLAI07)

May 5, 2014 updated by: CANDONI ANNA, University Hospital, Udine, Italy

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Udine, Italy, 33100
        • University Hospital, Udine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 years.
  • WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.
  • AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
  • All FAB subtypes except M3.
  • CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
  • Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
  • Adequate renal and liver function, i.e., creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
  • Written informed consent

Exclusion Criteria:

  • Blast crisis of chronic myeloid leukemia.
  • AML supervening after other myeloproliferative diseases.
  • AML de novo or secondary previously pretreated.
  • Concomitant malignant disease.
  • Active central nervous system (CNS) leukemia.
  • Active uncontrolled infection [NB severe systemic infection should be excluded].
  • Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
  • Cardiac ejection fraction of 50% or less.
  • Severe pulmonary dysfunction (CTC grade 3-4).
  • Severe concomitant neurological or psychiatric disease.
  • History of alcohol abuse.
  • HIV positivity.
  • Pregnancy.
  • Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
  • Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efficacy of FLAIMy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
Time Frame: one year
one year
RFS, DFS and OS.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
Time Frame: one year
one year
Evaluation of prognostic clinical relevance of biological features at onset.
Time Frame: one year
one year
Feasibility and outcome of consolidation with BMT.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: ANNA CANDONI, MD, UUNIVERSITY HOSPITAL, UDINE, ITALY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on FLAIMy - Fluda, Ida, Ara-C, Mylotarg

3
Subscribe