Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 16, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy

Original Primary Outcome Measures ^ICMJE

- adverse events in prephase and the following cycles of chemotherapy
- renal function parameters
- uric acid
- electrolytes (calcium,phosphate,potasium)
- mortality in prephase and the two following cycles of chemotherapy
- time and dose compliance of chemotherapy
- cross-over rate

Change History

Complete list of historical versions of study NCT00199043 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

response rate, incidence of tumor lysis syndrome

Original Secondary Outcome Measures ^ICMJE

- response rate
- incidence of tumor lysis syndrome

Descriptive Information

Brief Title ^ICMJE

Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

Official Title ^ICMJE

Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)

Brief Summary

In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Adult Acute Lymphocytic Leukemia
High-Grade Lymphoma

Intervention ^ICMJE

Drug: Allopurinol
Drug: Rasburicase

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients of the GMALL B-ALL/NHL-Study 2002
patients of the GMALL-Study 07/2003
patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
bulky disease (> 7.5 cm)
high LDH (> 2 x UNL)
uric acid >8 mg/dl/ >475µmol/L at diagnosis
leukocytes > 30 000/µl

Exclusion Criteria:

exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
asthma or severe, live-threatening atopic allergy in history
hypersensitivity against Uricacid
Glucose-6-Phosphate-Dehydrogenase deficiency
pretreatment with Rasburicase or Urikozyme™

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dieter Hoelzer, MD,PhD	++49(0)69 63015194	hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD	++49(0)69 63016365	goekbuget@em.uni-frankfurt.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00199043

Responsible Party

Study ID Numbers ^ICMJE

GMALL08

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital of Frankfurt, Medical Dept. II

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP