NCT00199108

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

4.2 years

First QC Date

September 12, 2005

Last Update Submit

August 16, 2022

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

CNS relapseALLTreatment

Outcome Measures

Primary Outcomes (1)

  • response rate after one application of DepoCyte

    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

    after each cycle and during follow-up

Study Arms (1)

Only 1 arm

EXPERIMENTAL
Drug: DepocytDrug: Dexamethasone

Interventions

DepocytDRUG
Only 1 arm
DexamethasoneDRUG
Only 1 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Publications (1)

  • Gokbuget N, Hartog CM, Bassan R, Derigs HG, Dombret H, Greil R, Hernandez-Rivas JM, Huguet F, Intermesoli T, Jourdan E, Junghanss C, Leimer L, Moreno MJ, Reichle A, Ribera J, Schmid M, Serve H, Stelljes M, Stuhlmann R, Hoelzer D; German Multicenter Study Group for Adult ALL and the European Working Group for Adult ALL. Liposomal cytarabine is effective and tolerable in the treatment of central nervous system relapse of acute lymphoblastic leukemia and very aggressive lymphoma. Haematologica. 2011 Feb;96(2):238-44. doi: 10.3324/haematol.2010.028092. Epub 2010 Oct 15.

    PMID: 20952517BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Dieter Hoelzer, MD,PhD

    University Hospital Frankfurt, Medical Dept. II

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

DE(1)