Relapsed/Refractory acute myeloid leukemia patients MedDRA version: 16.1 Level: LLT Classification code 10000889 Term: Acute myeloid leukemia without mention of remission System Organ Class: 100000004864
Conditions
Interventions
Trade Name: DACARBAZINA
Product Name: DACARBAZINA
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DACARBAZINA CITRATO
CAS Number: 64038-56-8
Other descriptive name: DACARBAZ
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged between 18 and 65 years • Signed written informed consent prior to beginning protocol specific procedures according to ICH/EU/GCP and national/local laws • Diagnosis of refractory acute myeloid leukaemia (after 1 cycle of induction therapy and 1 salvage therapy) or relapsed acute myeloid leukemia (after 1 salvage therapy) • Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral blood): MGMT/ß-Actin ratio (Western Blot analysis) not higher than 0.4 or MGMT activity (enzymatic determination) not exceeding 200 fM/mg protein • WHO performance status 0-3 • Adequate renal (serum creatinine 50%, as determined by echocardiogram • Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection • Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule • Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of study drugs (post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Patients aged less than 18 or more than 65 years • Acute promyelocytic leukaemia • Blast crisis of chronic myeloid leukaemia • AML supervening after other myeloproliferative disease • Previous treatment with any other experimental drug within 3 weeks prior to study entry • Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral blood): MGMT/ß-Actin ratio (Western Blot analysis) higher than 0.4 or MGMT activity (enzymatic determination) exceeding 200 fM/mg protein • Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit) • Severe heart failure requiring diuretics • Ejection fraction < 50% • Uncontrolled infections • WHO performance status = 4 • Severe concomitant neurological or psychiatric diseases • Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Dacarbazine in relapsed/refractory acute myeloid leukemia (AML) patients with MGMT-deficient;Secondary Objective: To establish the safety, the short-term response (within 1 cycle of treatment), the time of disease control and the fasibility of bone marrow transplantation in eligibles pazients following the Dacarbazine administration;Primary end point(s): Rate of complete remission (CR+CRi) after induction therapy;Timepoint(s) of evaluation of this end point: 1-2 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Stima della sopravvivenza globale (OS) • Stima della sopravvivenza libera da malattia (DFS) dalla remissione completa • Stima del tempo libero da complicanze (EFS) dall’arruolamento nello studio • Valutazione della tossicita’ • Percentuale delle remissioni complete e stima della OS, DFS, EFS in rapporto alle caratteristiche del paziente come eta’, performance status, conta dei globuli bianchi, caratteristiche morfologiche, citogenetiche e molecolari ;Timepoint(s) of evaluation of this end point: 2 YEARS | — |
Countries
Italy
Contacts
Public ContactGiulia De Luca
Segreteria Comitato Etico
Outcome results
None listed