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

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

Sponsored by:	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

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

ChemIDplus related topics:

Allopurinol Allopurinol sodium Rasburicase

U.S. FDA Resources

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)

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

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

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

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

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Allopurinol

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Hyperuricemia

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Rasburicase

Lymphoma

Acute lymphoblastic leukemia, adult

Additional relevant MeSH terms:

Antimetabolites

Neoplasms by Histologic Type

Antioxidants

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Protective Agents

Gout Suppressants

Pharmacologic Actions

Neoplasms

Pathologic Processes

Therapeutic Uses

Free Radical Scavengers

Antirheumatic Agents

ClinicalTrials.gov processed this record on October 10, 2008