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    Association details:
    Biomarker:CD33 positive
    Cancer:Acute Myelogenous Leukemia
    Drug:Mylotarg (gemtuzumab ozogamicin) (DNA replication inhibitor, CD33-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    06/16/2020
    Excerpt:
    MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for….treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older….treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    04/19/2018
    Excerpt:
    Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML)…
    Secondary therapy:
    cytarabine + daunorubicin
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Other recommended induction regimens for intermediate- or poor-risk disease include: standard-dose cytarabine (200 mg/m2 continuous infusion) for 7 days combined with daunorubicin (60 mg/m2 for 3 days) and GO for patients with CD33-positive AML (intermediate-risk AML)...
    Secondary therapy:
    cytarabine + daunorubicin
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    SCT Plus Immune Therapy in Average Risk AML/MDS

    Excerpt:
    ...- Disease must express a minimum of > or = 10% CD33 positivity for patients with AML...
    Trial ID:
    NCT02117297
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

    Excerpt:
    ...- Refractory or relapsed (ie, bone marrow blasts >5%) CD33-positive AML....
    Trial ID:
    NCT03727750
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse

    Excerpt:
    ...Histologically diagnosed CD33 positive acute myeloid leukemia (AML) in first relapse At least 6 months of complete remission...
    Trial ID:
    NCT00003131
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

    Excerpt:
    ...Diagnosis of recurrent or refractory acute myeloid leukemia CD33 positive Greater than 5% morphologically identified blasts in the marrow OR Diagnosis of myelodysplastic syndrome CD33 positive Greater than 5% morphologically identified blasts in the marrow (refractory anemia with excess blasts (RAEB) and RAEB in transformation)...
    Trial ID:
    NCT00008151
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

    Excerpt:
    ...- Diagnosis of CD33-positive AML by World Health Organization criteria....
    Trial ID:
    NCT00798213
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

    Excerpt:
    ...- Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did...
    Trial ID:
    NCT00660036
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

    Excerpt:
    ...- CD33 positive...
    Trial ID:
    NCT00049179
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

    Excerpt:
    ...Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment)...
    Trial ID:
    NCT00044733
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- CD33 positivity (> 20%)....
    Trial ID:
    NCT00909168
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

    Excerpt:
    ...- Patients with CD33 positive, resistant or relapsed AML....
    Trial ID:
    NCT00304447
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia

    Excerpt:
    ...- Adult Patients newly diagnosed as CD33-positive AML...
    Trial ID:
    NCT05189639
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

    Excerpt:
    ...- Patients must have CD33 positivity of >= 30%...
    Trial ID:
    NCT01548911
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

    Excerpt:
    ...- Blasts CD33-positive by flow cytometry...
    Trial ID:
    NCT00089050
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

    Excerpt:
    ...Patients with a morphologically proven diagnosis of CD33-positive AML and : 1....
    Trial ID:
    MYLOFRANCE2
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2023
    Title:

    2893 Gemtuzumab Ozogamicin for Patients with Newly Diagnosed CD33 Positive Acute Myeloid Leukemia: Results from a French Retrospective Observational Study

    Published date:
    11/02/2023
    Excerpt:
    Overall, GO appears safe and effective in real-world practice when added to induction therapy for treating patients with de novo CD33-positive AML.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Int J Hematol
    Title:

    Clinical outcomes of gemtuzumab ozogamicin for relapsed acute myeloid leukemia: single-institution experience

    Published date:
    11/20/2020
    Excerpt:
    We retrospectively evaluated the clinical efficacy and toxicity of gemtuzumab ozogamicin (GO) in patients with relapsed acute myeloid leukemia (AML)...Six patients responded to the treatment (31.6%) with 3 complete remissions (15.8%). Five patients had stable disease, and 8 patients did not show any response...CD33 positivity of leukemic cells was higher in responders than in nonresponders.
    DOI:
    10.1007/s12185-020-03023-4
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Lymphoma Myeloma Leuk
    Title:

    GEMTUZUMAB OZOGAMICIN COMBINED WITH INTENSIVE CHEMOTHERAPY IN ACUTE MYELOID LEUKEMIA PATIENTS RELAPSING AFTER ALLOGENIC STEM-CELL TRANSPLANTATION

    Published date:
    07/06/2020
    Excerpt:
    We included 18 consecutive AML patients relapsing after a first allo-HCT and treated with fractioned GO (fGO) and intensive chemotherapy...The median age was 40 years (range, 18-65)...The overall response rate was 72% (13/18) including 7 complete remissions...Our study suggests the feasibility, efficacy, and safety of a fractioned GO-based salvage regimen combined with intensive chemotherapy in CD33+ AML patients in the case of early relapse after an allo-SCT.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1016/j.clml.2020.07.001