Deutsches Leukämie-Studienregister
Studie: SAMBA

Kurzübersicht
Öffentlicher Titel JNJ-56022473 bei MDS und AML nach Versagen einer Therapie basierend auf hypomethylierenden Substanzen
Wissenschaftl. Titel Single agent JNJ-56022473 in MDS and AML patients failing hypomethylating agentbased therapy
Kurztitel SAMBA
Studiennummer KN/ELN LN_DEUTSC_2016_604
Studiengruppe Deutsche MDS
Studienart multizentrisch, einarmig, offen
Studienphase Phase II
Erkrankung Myelodysplastisches Syndrom (MDS) - Niedrigrisko und Intermediär I
Myelodysplastisches Syndrom (MDS) - Intermediär II und Hochrisiko
Myelodysplastisches Syndrom (MDS) - RAEB I
Myelodysplastisches Syndrom (MDS) - RAEB II
Leukämiestadium .
Einschlusskriterien
  • >=18 years of age
  • Diagnosis of AML or MDS
  • At least >= 5% BM blasts at the time of screening (done by central morphology)
  • At least one cytopenia (ANC < 1800/μL or platelet count < 100,000/μL or hemoglobin < 10 g/dL)
  • Failure to achieve complete or partial response or hematological improvement after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
  • Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
  • Intolerance to treatment with HMA (hypomethylating agents) defined by drug-related >= Grade 3 liver or renal toxicity leading to treatment discontinuation during the past two years
  • Failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation
  • Off all other treatments for AML/MDS for at least four weeks; Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated
  • No medical need for or patient opted not to receive induction chemotherapy
  • ECOG performance status of 0-2
  • Willing to adhere to the prohibitions and restrictions specified in the protocol
  • Signed informed consent
Ausschlusskriterien
  • 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 promyelocytic leukemia (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
  • Patients who are unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, or surgical sterilization) before entry, throughout the study and within 3 months after last study drug administration Female patients with reproductive potential who do not have a negative urine ß-HCG pregnancy test at screening and prior to the first study drug administration
  • Female patients with reproductive potential who do not have a negative urine beta-HCG pregnancy test at screening and prior to the first study drug administration
  • Female patients who are lactating
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 01.09.2016
Fallzahl 43
Studienleiter/in Platzbecker, Prof. Dr. med., Uwe
Kontaktperson f.
wissenschaftl. Anfragen
Platzbecker, Prof. Dr. med., Uwe
Ansprechpartner

Organisatorische Anfragen
Gloaguen, Silke
Tel: +49 (0)351 4584722
E-Mail: silke.gloaguen@uniklinikum-dresden.de

Kurzprotokoll Kurzprotokoll
Sponsoren GWT-TUD GmbH
Förderer Janssen
Registrierung in anderen Studienregistern European Clinical Trials Database - EUDRACT 2016-000327-10
Haupt- und Nebenzielkriterien
  • 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 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 (Hauptzielkriterium)
erstellt 11.10.2016 Student Studienregister
geändert 24.11.2016 Eva-Maria Ableidinger
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