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

Adult Acute Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199108
• Other study ID #: GMALL06
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2004
• Est. completion date: June 2008

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence

Intervention

Drug:
• Depocyt

• Dexamethasone

Locations

Country	Name	City	State
Germany	University Hospital, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gökbuget N, Hartog CM, Bassan R, Derigs HG, Dombret H, Greil R, Hernández-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate after one application of DepoCyte		one cycle
Secondary	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