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

NCT ID: NCT00199108

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-06-30

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

Conditions

Adult Acute Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Only 1 arm

Group Type: EXPERIMENTAL

Depocyt

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

Depocyt

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Nicola Goekbuget

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Hoelzer, MD,PhD

Role: STUDY_CHAIR

University Hospital Frankfurt, Medical Dept. II

Locations

University Hospital, Medical Dept. II

Frankfurt, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 20952517 (View on PubMed)

Other Identifiers

GMALL06

Identifier Type: -

Identifier Source: org_study_id