Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt - Tabular View

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Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

This study is ongoing, but not recruiting participants.

Study NCT00199108. Last updated on May 29, 2008. Information provided by Johann Wolfgang Goethe University Hospitals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

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

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 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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

response rate after one application of DepoCyte

Secondary Outcome 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

Condition ^†

Adult Acute Lymphocytic Leukemia

Intervention ^†

Drug: Depocyt
Drug: Dexamethasone

MEDLINE PMIDs

Links

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

German Leukemia Trial Registry This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

April 2004

Completion Date

June 2008

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00199108

Organization ID

GMALL06

Secondary IDs ^††

Study Sponsor ^†

Johann Wolfgang Goethe University Hospitals

Collaborators ^††

Investigators ^†

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital Frankfurt, Medical Dept. II

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2008

First Received Date ^†

September 12, 2005

Last Updated Date

May 29, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.