Status:
COMPLETED
Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
Lead Sponsor:
Northern Italy Leukemia Group
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this clinical study in adult ALL is to compare by risk category (1) the feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free survival in relation to the ac...
Detailed Description
A) Risk Classification Newly diagnosed patients are hierarchically clustered into very high, high and standard risk cases (VHR, HR, SR) using international risk criteria modified according to NILG: ...
Eligibility Criteria
Inclusion
- Age 18-65 years.
- 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.
- Full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria.
- Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
- ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
- Signed informed consent.
Exclusion
- Diagnosis of B-ALL (FAB L3 ALL/Burkitt's leukemia or lymphoma) and T-LL (T-cell lymphoblastic lymphoma).
- Down's syndrome.
- 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.
- Known HIV positive serology.
- Other active hematological or non-hematological cancer with life expectancy \<1 year.
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00795756
Start Date
January 1 2008
End Date
October 1 2013
Last Update
October 22 2014
Active Locations (16)
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1
USC Ematologia, Ospedale Civile
Alessandria, (al), Italy
2
USC Ematologia, Ospedali Riuniti
Bergamo, (bg), Italy, 24128
3
Divisione di Ematologia - Spedali Civili
Brescia, (bs), Italy
4
Divisione di Ematologia e TMO, Ospedale San Maurizio
Bolzano, (bz), Italy