Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003839

Trial Description

start of 1:1-Block title

Title

Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

AML-17

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill
them or deliver cancer-killing substances to them without harming normal cells. It is not
yet known if combining combination chemotherapy with monoclonal antibody therapy will kill
more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination
chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute
myeloid leukemia.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

OBJECTIVES:

- Determine the antileukemic activity of standard induction chemotherapy with or without
gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid
leukemia.

- Determine the overall survival of patients treated with these regimens.

- Determine the rate of response, disease-free survival, event-free survival, incidence
of relapse, and incidence of death of patients treated with these regimens.

- Determine the rate, type, and grade of toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to age (61-69 vs 70-75), CD33 positivity (less than 5% vs 5-19% vs 20-80% vs more
than 80% vs unknown), initial WBC before hydroxyurea administration if needed (less than
30,000/mm^3 vs at least 30,000/mm^3), and participating center. Patients are randomized to 1
of 2 treatment arms.

- Arm I:

- Induction (phase I): Patients receive gemtuzumab ozogamicin IV over 2 hours on
days 1 and 15.

- Induction (phase II/MICE regimen): Beginning between days 50 and 53, patients
receive mitoxantrone IV over 30 minutes on days 1, 3, and 5; etoposide IV over 1
hour on days 1-3; and cytarabine IV continuously on days 1-7. Bone marrow
evaluation is performed on day 29. Patients with partial remission (PR) receive a
second course of MICE chemotherapy regimen. Patients with complete remission (CR)
after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients
with progressive disease go off therapy.

- Consolidation: Beginning within 4 weeks of documentation of CR, patients receive
gemtuzumab ozogamicin IV over 2 hours on day 0; idarubicin IV on days 1, 3, and 5;
etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-5.
After at least day 30, patients receive a second consolidation course in the
absence of disease progression or unacceptable toxicity.

- Arm II:

- Induction (MICE regimen): Patients receive mitoxantrone, etoposide, and cytarabine
as in arm I induction. Bone marrow evaluation is performed on day 29. Patients
with PR receive a second course of MICE chemotherapy regimen. Patients with CR
after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients
with progressive disease go off therapy.

- Consolidation: Patients receive idarubicin, etoposide, and cytarabine as in arm I
consolidation.

Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6
months thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this
study within 3.75 years.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003839
  •   2012/05/11
  •   2003/01/24
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2005-001347-37 
  •   NCT00052299  (ClinicalTrials.gov)
  •   EORTC-06012  (European Organisation for Research and Treatment of Cancer - EORTC)
  •   EORTC-06012 
  •   AML-17 
  •   GIMEMA-AML-17 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Leukemia
  •   C92.0 -  Acute myeloid leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: cytarabine
  •   Drug: etoposide
  •   Drug: gemtuzumab ozogamicin
  •   Drug: idarubicin
  •   Drug: mitoxantrone hydrochloride
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Overall survival

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction
- Disease-free survival after CR/CRp
- Incidence of relapse after CR/CRp
- Incidence of death without relapse after CR/CRp
- Event-free survival
- Toxicity (highest grade) assessed by International Working Group CTC v2.0

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Portugal
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2002/09/30
  •   450
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   61   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia (AML)

- Bone marrow blasts at least 20% by bone marrow aspiration or biopsy

- FAB subtypes M0-M2 and M4-M7

- No acute promyelocytic leukemia (FAB subtype M3)

- Previously untreated primary or secondary AML, including AML after myelodysplastic
syndromes

- Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed

- No blast crisis of chronic myelogenous leukemia

- No AML supervening after other myeloproliferative diseases

- No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

- 61 to 75

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC less than 30,000/mm^3 (pretreatment with hydroxyurea for no more than 14 days
allowed)

Hepatic

- Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal

- Creatinine no greater than 3 times ULN

Cardiovascular

- No concurrent severe cardiovascular disease

- No arrhythmias requiring chronic treatment

- No congestive heart failure

- No symptomatic ischemic heart disease

Pulmonary

- No severe pulmonary dysfunction (CTC grade 3-4)

Other

- HIV negative

- No other uncontrolled infection

- No other concurrent malignant disease

- No severe concurrent neurological or psychiatric disease

- No prior alcohol abuse

- No psychological, familial, sociological, or geographical condition that would
preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent hematopoietic growth factors (filgrastim [G-CSF] or sargramostim
[GM-CSF]) except for life-threatening infection due to neutropenia

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior enrollment in this trial

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

[---]*

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • European Organisation for Research and Treatment of Cancer - EORTC
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma
    • Sergio Amadori, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma
    • Sergio Amadori, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/02/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.