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

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: May 29, 2008 History of Changes

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00199108

Purpose

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

Condition	Intervention	Phase
Adult Acute Lymphocytic Leukemia	Drug: Depocyt Drug: Dexamethasone	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Dexamethasone Cytarabine hydrochloride Dexamethasone acetate Doxiproct plus Cytarabine Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

response rate after one application of DepoCyte

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	April 2004
Estimated Study Completion Date:	June 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199108

Locations

Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital Frankfurt, Medical Dept. II

More Information

Additional Information:

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

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

No publications provided

Study ID Numbers:	GMALL06
Study First Received:	September 12, 2005
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00199108 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

CNS relapse
ALL
Treatment

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antimetabolites
Anti-Infective Agents
Disease Attributes
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Leukemia

Pathologic Processes
Therapeutic Uses
Lymphoma
Cytarabine
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents
Recurrence

ClinicalTrials.gov processed this record on November 30, 2009