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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.

Sponsored by: 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

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

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus   

U.S. FDA Resources

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

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

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

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

Keywords provided by Johann Wolfgang Goethe University Hospitals:
CNS relapse  
ALL  
Treatment  

Study placed in the following topic categories:
Dexamethasone
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Aggression
Lymphoma
Dexamethasone acetate
Cytarabine
Acute lymphoblastic leukemia, adult

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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