acute myeloid leukemia
Conditions
Interventions
Trade Name: REVLIMID*21CPS 10MG
Pharmaceutical Form: Tablet
INN or Proposed INN: lenalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: ARAC
Sponsors
AZIENDA OSPEDALIERA CARDARELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Male and female patients ≥ 70 years Written informed consent to participate in the clinical trial Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration within the past 14 days Diagnostic aspirate or biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy Previously untreated disease apart from growth factors Must have declined standard AML cytotoxic chemotherapy regimens WBC ≤ 50,000/mm³ History of prior myelodysplastic syndromes (MDS) allowed No acute promyelocytic leukemia (FAB M3) No blastic transformation of chronic myelogenous leukemia ECOG performance status 0-3 Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert`s syndrome or hemolysis, but not to liver dysfunction) Are the trial subjects under 18? no Number of subjects for this age range: 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
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Prior systemic chemotherapy for acute leukemia except hydroxyurea Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy Prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support Prior treatment for antecedent MDS with the exception of growth factors MDS At least 6 months since prior chemotherapy or radiotherapy for another malignancy Concurrent therapy for another malignancy Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible. Patients with an ECOG performance status of > 2 are ineligible. Patients with an ECOG performance status of 3, secondary to primary disease, may be enrolled at the discretion of the institutional investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To assess the antitumour efficacy of the combination regimen.;Secondary Objective: Secondary objectives: Determine the safety and toxicity parameters of the combination regimen Determine the relationship of cytogenetic abnormalities and response to treatment Determine the total response rate Determine the cytogenetic response rate;Primary end point(s): o To determine the complete response (CR) rate according to SWOG criteria. CRi (CR with incompolete hematologic recovery will be also considered) | — |
Countries
Italy
Outcome results
None listed