AML and MDS patients failing or being refractory to hypomethylating agent (HMA) treatment. MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10067096 Term: 5q minus myelodysplastic syndrome System Organ Class: 100000004864
Conditions
Interventions
Product Name: JNJ-56022473 (CSL-62) 100 mg
Product Code: JNJ-56022473 (CSL-62) 100 mg
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - signed informed consent - = 18 years of age - Must be able to adhere to the study visit schedule and other protocol requirements - Diagnosis of AML or MDS - At least one cytopenia (ANC =65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: - Previous treatment with a CD123 agent or T- or NK cell redirecting therapy - Patients having received intensive chemotherapy to treat HMA failure - Diagnosis of acute APL - WBC > 15 GPT/L - Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Active infection not adequately responding to appropriate therapy - Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilbert’s disease - ALT/AST > 2.5 x upper limit of normal - Serum creatinine > 2.0 mg/dL - Female patients who are pregnant or lactating - Patients who are unwilling to follow highly effective contraception requirements (including condom use for males with sexual partners, and for females: prescription of oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, surgical sterilization or true sexual abstinence) at least at screnning, throughout the study and within 3 months after last study drug administration. - Female patients with child-bearing potential who do not have a negative urine ß-HCG pregnancy test at screening and prior to the first study drug administration at visit 1 (day 0 of JNJ-56022473 treatment period) - Female patients who are lactating - Known hypersensitivity to the study drugs or active substances or excipients of the preparations - Suspicion of drug or alcohol abuse
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Toxicity as measured by NCI CTCAE 4.03 - Overall survival at 1 year - Progression-free-survival at 1 year - Overall hematological response rate at 12 months (either CR, PR, marrow-CR, HI, SD). Remission assessment according to Döhner et al. (AML patients) and Cheson et al. (MDS patients) - Quality of life as measured by EORTC-QLQ30 - Time to treatment failure - Duration of response (best overall response) - Association of response to molecular signature and immune cell function (additional translational project) ;Timepoint(s) of evaluation of this end point: - 1 year after enrollment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of JNJ-56022473 for the treatment of MDS and AML patients who have relapsed after or are refractory to treatment with HMAs;Secondary Objective: Safety, quality of life, Pharmacodymancs, AML evolution, progression;Primary end point(s): - Overall hematological response rate at 3 months (either CR, PR, marrow-CR, HI, SD);Timepoint(s) of evaluation of this end point: after 3 month of treatment | — |
Countries
France, Germany
Contacts
Public ContactGFM
Groupe Francophone des Myélodysplasies (GFM)
Outcome results
None listed