Overview

This trial is active, not recruiting.

Condition adult acute lymphocytic leukemia
Treatments depocyt, dexamethasone
Phase phase 2/phase 3
Sponsor Johann Wolfgang Goethe University Hospitals
Start date April 2004
End date June 2008
Trial size 20 participants
Trial identifier NCT00199108, GMALL06

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 DepoCyte at least once. Treatment may be repeated during induction phase each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3 weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary objective is the response rate after one application of DepoCyte. Further objectives are the compilation of data regarding safety and toxicity

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
response rate after one application of DepoCyte
time frame:

Secondary Outcomes

Measure
response rate at later time-points, toxicity (WHO), death in induction and CR, time to neurological progression, frequency of improvement in pre-existing meningeal-disease related neurological symptoms, Karnofsky Performance Status, Survival
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title A Phase-2 Clinical Study to Determine the Efficacy and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of CNS Relapse in Adult Patients With Acute Lymphoblastic Leukemia or Very Aggressive Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Johann Wolfgang Goethe University Hospitals.