A Randomized Pilot Study on Central Nervous System (CNS) Prophylaxiswith Liposome-Encapsulated Cytarabine (DepoCyte) in a Population of Adult Patientswith Acute Lymphoblastic Leukemia (ALL) Treated with an Updated and Lineage-TargetedMinimal Residual Disease (MRD)-Oriented Postremission Strategy. - NILG-ALL 10/07

ILG0 个研究点开始时间: 2008年4月8日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•ALL Prospective Register
•1. Age 18+ years.
•2. Diagnosis of untreated ALL with B-/T-precursor phenotype or B/T-LL, either de novo or secondary to chemo-radiotherapy for other cancer.
•3. Signed informed consent.
•Inclusion criteria
•1. Age 18-65 years.
•2. Diagnosis of untreated ALL with B-/T-precursor phenotype or B-cell lymphoblastic lymphoma (B-LL), either de novo or secondary to chemo-radiotherapy for other cancer.
•3. Full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria.
•4. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
•5. ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
•6. Signed informed consent.
•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) no
•F.1.3.1 Number of subjects for this age range

•1. Diagnosis of B-ALL (FAB L3 ALL/Burkitt?s leukemia or lymphoma) and T-LL (T-cell lymphoblastic lymphoma).
•2. Down?s syndrome.
•3. Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL/LL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL/LL), and severe neurological or psychiatric disorder that impairs the patient?s ability to understand and sign the informed consent, or to cope with the intended treatment plan.
•4. Known HIV positive serology.
•5. Other active hematological or non-hematological cancer with life expectancy <1 year.
•6. Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods), unless therapeutic aborption/early discharge is carried out.

发起方

ILG