Untreated patients aged 60> years with Acute Myeloid Leukemia MedDRA version: 15.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: tosedostat
Product Code: CHR-2797
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TOSEDOSTAT
CAS Number: 238750-77-1
Current Sponsor code: CHR-2797
Other descriptive name: BB-761
Sponsors
AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged > 60 years Signed informed consent Morphologically confirmed diagnosis of acute myeloid leukemia by bone marrow aspiration within the past 14 days Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: HIV infection HCV positivity Active second malignancy Diagnosis of relapsed acute promyelocitic leukemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the complete remission (CR)rate of the combination regimen low dose ARA-C + Tosedostat;Secondary Objective: To determine the safety and toxicity of the combination regimen. To determine response rate of stable disease or better. To determine the relationship of single cytogenetic abnormalities with response to treatment. To determine the overall and progression-free survival of patients completing the treatment;Primary end point(s): To assess the complete remission (CR)rate of the combination regimen low dose ARA-C + Tosedostat;Timepoint(s) of evaluation of this end point: First time point: 2 months after the start of therapy. Subsequent time points: every 2 months, by bone marrow biopsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the safety and toxicity of the combination regimen To determine response rate of stable disease or better To determine the overall and progression-free survival;Timepoint(s) of evaluation of this end point: Last patient, last visit. | — |
Countries
Italy
Contacts
Public ContactHematology Clinical Trial Office
Presidio Ospedaliero San Salvatore/Ospedali Riuniti Marche Nord
Outcome results
None listed