Treatment of Hyperuricemia With Rasburicase in Patients W... | NCT00199043

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

NCT00199043

Sponsor

Goethe University

Status

Completed

Last Update Posted

Mar 17, 2023Actual

Enrollment

80Actual

Phase

Phase 3

Conditions

Adult Acute Lymphocytic Leukemia
High-grade Lymphoma

Interventions

Allopurinol
Rasburicase

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2023

Last Update Posted Date

Mar 17, 2023Actual

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
Only 1 arm	Experimental		Drug: Allopurinol Drug: Rasburicase

Name	Type	Description	Arm Group Labels	Other Names
Allopurinol	Drug		Only 1 arm
Rasburicase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	after cycle 1	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
response rate, incidence of tumor lysis syndrome	after cycle 1	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 Uric acid
Glucose-6-Phosphate-Dehydrogenase deficiency
pretreatment with Rasburicase or Urikozyme™

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dieter Hoelzer, MD,PhD	University Hospital of Frankfurt, Medical Dept. II	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Medical Dept. II		Frankfurt		60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000493	Allopurinol
C469709	rasburicase

Ancestor Terms

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided