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 sitesApril 8, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: 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.
Sponsor: ILG
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

April 8, 2008

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ILG

•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.

•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.