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: 100000012984 MedDRA version: 20.0 Level: LLT Classification code 10067096 Term: 5q minus myelodysplastic syndrome System Organ Class: 100000074219
Conditions
Interventions
Product Name: JNJ-56022473 (CSL362) 100 mg
Product Code: JNJ-56022473 (CSL362) 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 = 5% BM blasts at the time of screening (done by central morphology) - 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 - Subjects with autoimmune disease with either a chronic (viral, bacterial, or fungal) infection, a prior history of recurrent serious infection, or a clinically important active infection - Subjects who have a history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics or have active systemic hepatitis infection requiring treatment or other clinically active liver disease - 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 screening, 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 the JNJ-56022473 treatment period - Known hypersensitivity to the study drugs or active substances or excipients of the preparations - Suspicion of drug or alcohol abuse - Subject is in custody by order of an authority or a court of law - Participation in another clinical study during the preceding 3 months (last treatment from previous study to first treatment of this study) - Exclusion periods from other studies or simultaneous participation in other clinical studies - Treatment with any investigational drug within 4 weeks before first administration of present trial drug or within less than 5 half-lives of the investigational drug before treatment with the present trial drug, whichever is longer. - Criteria which in the opinion of the investigator precluded participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety - Previous assignment to treatment during this study - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) - Subject is an employee of GWT-TUD GmbH
Design outcomes
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, PD, 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: - LPLV | — |
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) [20] and Cheson et al. (MDS patients) [21] - 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 | — |
Countries
France, Germany
Contacts
Public ContactMedical Consulting
GWT-TUD GmbH
Outcome results
None listed