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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, May 2008

First Received: September 12, 2005 Last Updated: May 16, 2008 History of Changes

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00199043

Purpose

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.

Condition	Intervention	Phase
Adult Acute Lymphocytic Leukemia High-Grade Lymphoma	Drug: Allopurinol Drug: Rasburicase	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Allopurinol sodium Rasburicase Allopurinol

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

response rate, incidence of tumor lysis syndrome

Estimated Enrollment:	80
Study Start Date:	May 2003

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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™

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199043

Contacts

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

Locations

Germany
University Hospital, Medical Dept. II	Recruiting
Frankfurt, Germany, 60590
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
Principal Investigator: Dieter Hoelzer, MD,PhD
Sub-Investigator: Nicola Goekbuget, MD

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital of Frankfurt, Medical Dept. II

More Information

Additional Information:

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

German Leukemia Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GMALL08
Study First Received:	September 12, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00199043 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Allopurinol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gout Suppressants
Leukemia
Pathologic Processes
Therapeutic Uses
Free Radical Scavengers
Lymphoma
Immunoproliferative Disorders

Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Hyperuricemia
Enzyme Inhibitors
Rasburicase
Protective Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009