A PHASE III STUDY OF THE ADDITION OF GEMTUZUMAB OZOGAMICIN (MYLOTARG®) DURING INDUCTION THERAPY VERSUS STANDARD INDUCTION WITH DAUNOMYCIN AND CYTOSINE ARABINOSIDE FOLLOWED BY CONSOLIDATION AND SUBSEQUENT RANDOMIZATION TO POST-CONSOLIDATION THERAPY WITH GEMTUZUMAB OZOGAMICIN (MYLOTARG®) OR NO ADDITIONAL THERAPY FOR PATIENTS UNDER AGE 61 WITH PREVIOUSLY UNTREATED DE NOVO ACUTE MYELOID LEUKAEMIA (AML)
- Conditions
- Previously untreated de novo acute myeloid leukemiaMedDRA version: 8.1Level: LLTClassification code 10000886Term: Acute myeloid leukemia
- Registration Number
- EUCTR2006-002743-89-SE
- Lead Sponsor
- Southwest Oncology Group (SWOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 684
Induction Registration:
a. Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration.
Date of bone marrow aspiration/biopsy
b. Patients must have reached their 18th birthday but not reached their 61st birthday.
c. Patients must have a Zubrod performance status of 0 - 3.
d. Patient must have a bilirubin = 2 x Institutional Upper Limit of Normal (IULN). Patients must also have SGOT (AST) = 3 x IULN and SGPT (ALT) = 3 x IULN. Studies must be performed within 14 days prior to registration.
e. Patients must have a normal left ventricular function with an ejection fraction = 50% as measured by MUGA scan or two-dimensional echocardiogram within 42 days prior to registration.
h. Pretreatment pathology materials must be submitted for morphologic review as described in Section 12.0. Collection of blood and marrow specimens for pathology review must be completed within 14 days prior to registration. Failure to submit pathology materials will render the patient ineligible.
i. Patients must be registered on SWOG-9007, the cytogenetics protocol. Collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. Pretreatment specimens of blood or bone marrow must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenic analysis. Note that this protocol also requires submission of remission and relapse specimens.
m. Patients who have known liver disease or known Hepatitis B(HbsAg positive) or Hepatitis C infection are not eligible. If viral status is not known, patients are eligible for study.
o. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
f. Patients with unstable cardiac arrhythmias or unstable angina are not eligible.
g. Patients must not have received systemic chemotherapy or more than one dose of intrathecal chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted.
l. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
k. Patients must not be pregnant or nursing because gemtuzumab ozogamicin may cause fetal harm and because of the potential for serious adverse reactions in nursing infants from the drug. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method