Open label, non-randomized, phase II study on fractionedcyclophosphamide, vincristine, liposomal doxorubicin or doxorubicin,and dexamethasone (MY HYPER-CVAD) in the treatment of relapsedrefractory adult acute lymphoid leukemia - All 0206

Conditions: refractory adult acute lymphoid leukemia
MedDRA version: 9.1Level: LLTClassification code 10000846Term: Acute lymphocytic leukaemia

Registration Number: EUCTR2007-003884-30-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 <2.5x ULN, bilirubin <1.5x
ULN, and creatinine <1.5x ULN.
· Age 18 years or greater.
· Documentation of written informed consent to participate in the trial.
· Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other
study procedures.
· at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full
recovery from prior toxicities.
· either men or women, accepting to practice effective contraception during the entire study period
unless documentation of infertility exists.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and the anti-leukemic activity of Hyper-CVAD in patients with ALL, relapsed<br>after or refractory to chemotherapy.;Secondary Objective: To assess the overall survival.<br>· To assess the relapse free survival<br>· 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)<br>- CR rate after any treatment cycle and at the end of the study

Secondary Outcome Measures