Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.
There are no controlled trials demonstrating efficacy and safety using Mylotarg in combination with other chemotherapeutic agents. Therefore, Mylotarg should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.
Severe myelosuppression occurs when Mylotarg is used at recommended doses.
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS
Mylotarg administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal. In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of Mylotarg and resolved. Mylotarg infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Mylotarg treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome. Since patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome, physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/μL prior to administration of Mylotarg. (See WARNINGS.)
Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of Mylotarg as a single agent, as part of a combination chemotherapy regimen, and in patients without a history of liver disease or hematopoietic stem cell transplant (HSCT). Patients who receive Mylotarg either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg in combinations with other chemotherapy are at increased risk for developing VOD, including severe VOD. Death from liver failure and from VOD has been reported in patients who received Mylotarg. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes. However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity. (See WARNINGS and ADVERSE REACTIONS sections.)
Mylotarg® (gemtuzumab ozogamicin for Injection) is a chemotherapy agent composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic, calicheamicin, isolated from fermentation of a bacterium, Micromonospora echinospora ssp. calichensis.
Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The safety and efficacy of Mylotarg in patients with poor performance status and organ dysfunction has not been established.
The effectiveness of Mylotarg is based on OR rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival, compared to any other treatment.
Published Studies Related to Mylotarg (Gemtuzumab Ozogamicin)
Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. [2011.05.19]
We report the results of a prospective, randomized phase 3 trial evaluating the use of gemtuzumab ozogamicin (GO) in an intensive consolidation approach in 657 patients 17-60 years of age. Patients in first complete remission (CR1) after cytarabine and standard- or high-dose daunorubicin induction received 2 cycles of consolidation with high-dose cytarabine followed by peripheral blood progenitor cell collection...
Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial. [2011.02.01]
PURPOSE: Antibody-directed chemotherapy for acute myeloid leukemia (AML) may permit more treatment to be administered without escalating toxicity. Gemtuzumab ozogamicin (GO) is an immunoconjugate between CD33 and calicheamicin that is internalized when binding to the epitope. We previously established that it is feasible to combine GO with conventional chemotherapy. We now report a large randomized trial testing the addition of GO to induction and/or consolidation chemotherapy in untreated younger patients... CONCLUSION: A substantial proportion of younger patients with AML have improved survival with the addition of GO to induction chemotherapy with little additional toxicity.
Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19). [2010.05]
This study compared two schedules of low-dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukaemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best supportive care or a course of GO according to one of two schedules: 3 mg/m(2) on days 1, 3 and 5 (arm A), or GO 6 mg/m(2) on day 1 and 3 mg/m(2) on day 8 (arm B)...
Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study. [2010.04.01]
In older patients with acute myeloid leukemia (AML), the prevention of relapse has remained one of the major therapeutic challenges, with more than 75% relapses after complete remission. The anti-CD33 immunotoxin conjugate gemtuzumab ozogamicin (GO) has shown antileukemic remission induction activity in patients with relapsed AML...
Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside. [2002.06.15]
We investigated treatment with gemtuzumab ozogamicin (GO) in 51 patients aged 65 years or older with newly diagnosed acute myeloid leukemia (AML), refectory anemia (RA) with excess of blasts in transformation, or RA with excess blasts. GO was given in doses of 9 mg/m(2) of body-surface area on days 1 and 8 or, therapeutically equivalently, on days 1 and 15, with or without interleukin 11 (IL-11; 15 microg/kg per day on days 3 to 28), with assignment to IL-11 treatment made randomly...
Clinical Trials Related to Mylotarg (Gemtuzumab Ozogamicin)
Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS) [Terminated]
To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but
nonmyeloablative preparative regimen in older or medically infirm patients undergoing
mini-allogeneic peripheral blood stem cell transplantation
1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable
with this strategy.
2. To evaluate disease-free and overall survival and relapse rates.
3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and
mobilized DLI in patients not achieving complete remission.
Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS [Completed]
The goal of this clinical research study is to find the highest safe dose of Mylotarg that
can be combined with chemotherapy in patients receiving allogeneic bone marrow
transplantation. Researchers will study the effects of this treatment combination on
patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic
1. To determine the safety and maximum tolerated dose of Mylotarg as part of a
reduced-intensity preparative regimen patients undergoing related, mismatched-related or
matched unrelated donor transplantation.
1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable
with this strategy.
2. To evaluate the incidence and severity of GVHD in this population
3. To evaluate disease-free and overall survival and relapse rates.
Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk [Active, not recruiting]
The main objective of the study is to improve outcome of younger patients (between 18-60
years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In
this population, in the absence of bone marrow transplantation, event free survival (EFS) is
estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin
(MYLOTARGÂ®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To
test this hypothesis, the Groupe Ouest Est d'Etude des LeucĂ©mies et Autres Maladies du Sang
(GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III
trial in 29 French centers.
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS) [Completed]
The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine)
given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid
leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety
of this drug combination will also be studied.
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia [Completed]
The purpose of this study is to evaluate the effect of corticosteroids on the frequency and
severity of Mylotarg® infusion-related adverse events, to evaluate the effect of
corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete
response with incomplete platelet recovery (CRp) at one-month post treatment.
Reports of Suspected Mylotarg (Gemtuzumab Ozogamicin) Side Effects
Febrile Neutropenia (15),
Multi-Organ Failure (12),
Atrial Fibrillation (7),
Pleural Effusion (6),
White Blood Cell Count Decreased (6), more >>
Page last updated: 2011-12-09