refractory adult acute lymphoid leukemia MedDRA version: 9.1 Level: LLT Classification code 10000846 Term: Acute lymphocytic leukaemia
Conditions
Interventions
Trade Name: METHOTREXATE*INIET 1FL 1G 10ML
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Methotrexate
Concentration unit: % percent
Concentration type: equal
Concentratio
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Diagnosis of ALL (any type included), in patients who: - have relapsed after conventional chemotherapy* or, - are refractory to at least 1 cycle of chemotherapy* · ECOG Performance score of 0-3 · Adequate hepatic and renal function, as defined by serum transaminases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Treatment with any investigational agent within 3 weeks prior to study therapy. · Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. · Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to: - Presence of central nervous system (CNS) leukemia. - Active uncontrolled bacterial infection. - Known human immunodeficiency virus (HIV) infection. - Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months. - Pregnancy or breast-feeding. - Malabsorption syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and the anti-leukemic activity of Hyper-CVAD in patients with ALL, relapsed after or refractory to chemotherapy.;Secondary Objective: To assess the overall survival. · To assess the relapse free survival · To assess the feasibility of allogeneic stem cell transplantation (SCT) in CR>1 after Hyper-CVAD;Primary end point(s): Type, frequency, severity, timing and relatedness of adverse events (AE) - CR rate after any treatment cycle and at the end of the study | — |
Countries
Italy
Outcome results
None listed