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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00199108
Recruitment Status : Unknown
Verified May 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia Drug: Depocyt Drug: Dexamethasone Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2004
Estimated Study Completion Date : June 2008





Primary Outcome Measures :
  1. response rate after one application of DepoCyte

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199108


Locations
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Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Study Chair: Dieter Hoelzer, MD,PhD University Hospital Frankfurt, Medical Dept. II

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00199108     History of Changes
Other Study ID Numbers: GMALL06
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Recurrence
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents