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Completed

NCT Number: NCT00199108

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

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

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Key information

Conditions

Adult Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depocyt

Drug

Dexamethasone

Drug

Primary outcomes

  1. response rate after one application of DepoCyte

    Time frame: one cycle

Secondary outcomes

  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

    Time frame: after each cycle and during follow-up

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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