Status:
COMPLETED
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt
Lead Sponsor:
Goethe University
Conditions:
Adult Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy with intrathecal Dep...
Eligibility Criteria
Inclusion
- proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse
- CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan indicating the presence of meningeal involvement
- in combined relapse in CNS and other locations: systemic therapy with CNS active drugs can be postponed for at least 2 weeks
- Karnofsky Performance Score is \> or = 60%
- 18 years of age or older
- free of uncontrolled infection
- recovered from any grade III / IV toxicities attributable to prior treatment with the exception of hematotoxicity
- patient not pregnant or breast feeding and effective methods to prevent pregnancy
- free from severe heart, lung, liver or kidney dysfunction
- written informed consent
Exclusion
- failed to respond (as defined by no clearance of the CSF) to \> 1 dose of prior i.th. MTX or ARAC or triple therapy
- history of neurotoxicity (grade III - IV) attributed to i.th. or systemic HD therapy with MTX or ARAC
- prior CNS relapse \< 1 month before
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00199108
Start Date
April 1 2004
End Date
June 1 2008
Last Update
August 18 2022
Active Locations (1)
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1
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590