Acute Myeloid Leukemia
Conditions
Interventions
See 'J: Aanvullende informatie'.
Sponsors
MacroGenics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have a confirmed diagnosis of primary or secondary AML (any subtype except acute promyelocytic leukemia [APL]) according to World Health Organization (WHO) classification. 2. Patients with AML must meet one of the following criteria: a Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following: - An intensive induction attempt, per institution. Induction attempts include high dose and/or standard-dose cytarabine +/- an anthracyclines/anthracenedione +/- and anti-metabolite, with or without growth factor or targeted therapy containing regimes. Examples include but are not limited to: 1. One cycle of high dose cytarabine (HiDAC) containing regimen 2. One cycle of liposomal cytarabine and daunorubicin 3. Two cycles of standard dose cytarabine containing regimen - For adults who are age 75 years or older, who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimes, 1 or 2: 1. >= 2 but = 2 but
Exclusion criteria
Exclusion criteria: 1. Prior history of allogeneic stem cell transplantation 2. Prior treatment with an anti-CD123-directed agent. 3. Need for concurrent other cytoreductive chemotherapy 4. Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation) 5. Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed. 6. Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1. 7. Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution 8. Use of immunosuppressant medications in the 2 weeks prior to study drug administration (Cycle 1 Day 1) 9. Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study drug administration (Cycle 1 Day 1) 10. Known central nervous system (CNS) leukemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy based on CR/CRh rate: Proportion of patients achieving a best response of CR (morphologic CR, cytogenetic CR, molecular CR, or CRh per Interworking Group AML response criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint: response rate, duration of response, event-free survival, overall survival and transplantation rate | — |
Countries
Netherlands
Outcome results
None listed