European Leukemia Trial Registry
Trial: SAMBA

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Public Title JNJ-56022473 bei MDS und AML nach Versagen einer Therapie basierend auf hypomethylierenden Substanzen
Short Title SAMBA
Id KN/ELN LN_DEUTSC_2016_603
Trialgroup Deutsche MDS
Type of Trial multicentric, single-group, open-label
Phase Phase II
Disease Acute myeloid leukemia(AML) AML all subtypes without FAB M3
Stage of Disease relapsed/refractory
Inclusion Criteria
  • ≥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
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 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 -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
Age >= 18 years
Status Closed
Start of Recruitment 01.09.2016
Target Sample Size 43
Leader Platzbecker, Prof. Dr. med., Uwe
Scientific Contact Platzbecker, Prof. Dr. med., Uwe (Affliliation)
Contact Person

Administrative needs
Gloaguen, Silke
Tel: +49 (0)351 4584722
Email: silke.gloaguen@uniklinikum-dresden.de

Shortprotocol Shortprotocol
Sponsors GWT-TUD GmbH
Supporters Janssen
Other Registers European Clinical Trials Database - EUDRACT 2016-000327-10
Outcomes
  • 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 (Primary Outcome)
created 11.10.2016 Student Studienregister
changed 21.03.2018 Martina Wolkenfeld
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