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

Primary Purpose

Adult Acute Lymphocytic Leukemia, High-grade Lymphoma

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Allopurinol

Rasburicase

About this trial

This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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™

Sites / Locations

University Hospital, Medical Dept. II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Only 1 arm

Arm Description

Outcomes

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

after cycle 1

Secondary Outcome Measures

response rate, incidence of tumor lysis syndrome

after cycle 1

Full Information

NCT ID

NCT00199043

First Posted

September 12, 2005

Last Updated

March 15, 2023

Sponsor

Goethe University

1. Study Identification

Unique Protocol Identification Number

NCT00199043

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Goethe University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Acute Lymphocytic Leukemia, High-grade Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Only 1 arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Intervention Type

Drug

Intervention Name(s)

Rasburicase

Primary Outcome Measure Information:

Title

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

Description

after cycle 1

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

response rate, incidence of tumor lysis syndrome

Description

after cycle 1

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Hoelzer, MD,PhD

Organizational Affiliation

University Hospital of Frankfurt, Medical Dept. II

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital, Medical Dept. II

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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