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

Primary Purpose

Adult Acute Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Depocyt
Dexamethasone
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia focused on measuring CNS relapse, ALL, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital, Medical Dept. II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Only 1 arm

Arm Description

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
August 16, 2022
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT00199108
Brief Title
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 2004 (Actual)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Lymphocytic Leukemia
Keywords
CNS relapse, ALL, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Only 1 arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Depocyt
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
response rate after one application of DepoCyte
Time Frame
one cycle
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD,PhD
Organizational Affiliation
University Hospital Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20952517
Citation
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.
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Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

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