Previously untreated de novo acute myeloid leukemia MedDRA version: 8.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia
Conditions
Interventions
Trade Name: Mylotarg
Product Name: Mylotarg
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: GEMTUZUMAB OZOGAMICIN
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Southwest Oncology Group (SWOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.1 To compare disease-free survival (DFS) of patients under age 56 with previously untreated, de novo, non-M3, AML who receive gemtuzumab ozogamicin as post-consolidation therapy versus patients who receive no post-consolidation therapy. 1.2 To compare the complete remission (CR) rate achieved by the addition of gemtuzumab ozogamicin to standard induction chemotherapy to that achieved with standard induction chemotherapy. The durability of complete response will also be measured. ;Secondary Objective: 1.3 To estimate the frequency and severity of toxicities of the addition of gemtuzumab ozogamicin to induction therapy and post-consolidation therapy. 1.4 To evaluate the prognostic significance of CD33 expression on the response rate of those patients who receive gemtuzumab ozogamicin. 1.5 To evaluate the prognostic significance of FLT3 mutations prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with gemtuzumab ozogamicin. 1.6 To evaluate the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected before and after consolidation therapy and after post-consolidation therapy with gemtuzumab ozogamicin. ;Primary end point(s): Disease-free survival (DFS) of patients who receive gemtuzumab ozogamicin as post-consolidation therapy versus patients who receive no post-consolidation therapy. Complete remission (CR) rate achieved by the addition of gemtuzumab ozogamicin to standard induction chemotherapy to that achieved with standard induction chemotherapy. | — |
Countries
Sweden
Outcome results
None listed