Treatment of relapsed/refractory leukemia with intravenous administration of Dacarbazine

• Conditions: Relapsed/Refractory acute myeloid leukemia patients; MedDRA version: 16.1Level: LLTClassification code 10000889Term: Acute myeloid leukemia without mention of remissionSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-001303-52-IT
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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 < 2 x the institutional ULN) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST = 3 x ULN) function, unless considered due to organ leukemic involvement
•-Left Ventricular Ejection Fraction (LVEF) >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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified