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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CANDONI ANNA, University Hospital, Udine, Italy
ClinicalTrials.gov Identifier:
NCT00909168
First received: May 26, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by University Hospital, Udine, Italy:

Primary Outcome Measures:
  • Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • RFS, DFS and OS. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Evaluation of prognostic clinical relevance of biological features at onset. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Feasibility and outcome of consolidation with BMT. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Efficacy of FLAIMy 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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909168

Locations
Italy
University Hospital, Udine
Udine, Italy, 33100
Sponsors and Collaborators
University Hospital, Udine, Italy
Investigators
Study Director: ANNA CANDONI, MD UUNIVERSITY HOSPITAL, UDINE, ITALY
  More Information

No publications provided

Responsible Party: CANDONI ANNA, Division of Hematology, SM MISERICORDIA HOSPITAL, University Hospital, Udine, Italy
ClinicalTrials.gov Identifier: NCT00909168     History of Changes
Other Study ID Numbers: MYFLAI07
Study First Received: May 26, 2009
Last Updated: May 5, 2014
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by University Hospital, Udine, Italy:
Induction chemotherapy
Fludarabine
Gemtuzumab Ozogamicin

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014