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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199108

Enrollment

Registered

2005-09-20

Start date

2004-04-30

Completion date

2008-06-30

Last updated

2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

CNS relapse, ALL, Treatment

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

Interventions

DRUGDepocyt

DRUGDexamethasone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
response rate after one application of DepoCyte	one cycle

Secondary

Measure	Time frame
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	after each cycle and during follow-up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026