Adult Acute Lymphocytic LeukemiaPhase 3NCT00199043
Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
A Phase 3 study testing Allopurinol and Rasburicase in people with Adult Acute Lymphocytic Leukemia and High-grade Lymphoma, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Adult Acute Lymphocytic Leukemia, High-grade Lymphoma
- What is being tested?
- Allopurinol and Rasburicase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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™
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Being tested
- Allopurinol, Rasburicase
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
RasburicaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Only 1 arm | Experimental | Not described Receives: Drug: Allopurinol; Drug: Rasburicase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (1)
response rate, incidence of tumor lysis syndrome
after cycle 1
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD,PhD, Study chair, University Hospital of Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199043
- Sponsor's protocol ID
- GMALL08
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2005
- Last updated
- 17 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00199043
- Acronym / sponsor ID
- GMALL08
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only 1 arm | Experimental | Drug: Allopurinol, Drug: Rasburicase |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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™
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol | Drug | Only 1 arm |
| Rasburicase | Drug | Only 1 arm |
Primary outcome
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
Time frame: 3 weeks
after cycle 1
1 secondary outcome
response rate, incidence of tumor lysis syndrome
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Hoelzer, MD,PhD study chair
University Hospital of Frankfurt, Medical Dept. II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allopurinol and Rasburicase in people with Adult Acute Lymphocytic Leukemia and High-grade Lymphoma, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.