Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 2NCT01564277
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
A Phase 2 study testing rasburicase and allopurinol in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- What is being tested?
- rasburicase and allopurinol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2011to 28 May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) status of 0-3
- Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS)
- Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by:
- A diagnosis of acute myeloid leukemia (AML), or
- A diagnosis of blast-phase chronic myeloid leukemia (CML), or
- A diagnosis of high-grade myelodysplastic syndrome (MDS) with >= 10% blast bone marrow blast involvement, or
Show all 9Show fewer
- Acute lymphoblastic leukemia (ALL), or
- Burkitt leukemia/lymphoma
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- History of asthma
- History of severe or life threatening atopic allergy
- Hypersensitivity to uricases
- Known prior sensitivity to allopurinol
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Recent prior history of uricolytic therapy defined as therapy within the last 7 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.
Read the detailed description
PRIMARY OBJECTIVES:
- To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different single low doses of rasburicase followed by allopurinol in 2 treatment arms.
SECONDARY OBJECTIVES:
- To estimate the proportion of patients requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL on day 2 through day 6.
II. To identify differential characteristics of the patients who do not respond to treatment.
III. To measure the area under the plasma uric acid concentration-time curve (AUC) from baseline (day 1) to day 7, time to plasma uric acid level less than or equal to 7.5mg/dL.
IV. To evaluate the rate of patients requiring hemodialysis (HD) V. To evaluate the safety of low single-doses of rasburicase. VI. To evaluate the rate of patients expressing a doubling of serum creatinine.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive 1.5mg of rasburicase intravenously (IV) over 30 minutes on day 1* and allopurinol orally (PO) once daily (QD) on days 1-6.
ARM II: Patients receive 3 mg of rasburicase IV over 30 minutes on day 1* and allopurinol PO QD on days 1-6.
NOTE: *Patients with serum uric acid >= 7.5mg/dl also receive rasburicase IV on days 2-3.
After completion of study treatment, patients are followed up at 30 days.
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Being tested
- rasburicase, allopurinol
- Medical subject headings
- Congenital Abnormalities, Blast Crisis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rasburicaseDrug
Also called Elitek, NK-631, recombinant urate oxidase
Given IV
allopurinolDrug
Also called 4'-HPP, ALLO, Zyloprim
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (1.5mg rasburicase) | Experimental | Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6. Receives: Drug: rasburicase; Drug: allopurinol |
| Arm II (3 mg rasburicase) | Experimental | Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6. Receives: Drug: rasburicase; Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
The proportion of patients able to achieve and/or maintain a uric acid level =< 7.5mg/dL for each treatment arm.
Measured: Within 24 hours of rasburicase treatment
Secondary outcomes (5)
Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL
Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL by treatment arm.
Measured: Up to day 7
Baseline White Blood Cell Count by Response
The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =< 7.5mg/dL) and no CR (patients with uric acid level > 7.5mg/dL).
Measured: Up to day 7
Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7
The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7
Measured: Up to day 7
Safety of Low Single-doses of Rasburicase.
The number of patients with any adverse events .
Measured: up to day 7
Number of Patients Experiencing a Doubling of Serum Creatinine
Count of participants experiencing a doubling of serum creatinine
Measured: up to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study start29 Sep 2011
- Primary completion28 May 2015
- Study completion28 May 2016
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eunice Wang, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564277
- Sponsor's protocol ID
- I 197711
- Other IDs
- NCI-2011-03231, I 197711, P30CA016056
- Status last verified
- Dec 2017
- First submitted
- 2 Mar 2012
- Last updated
- 9 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
- ClinicalTrials.gov ID
- NCT01564277
- Acronym / sponsor ID
- I 197711
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Sep 2011 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- 28 May 2016 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Posted 8 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.
Detailed description
PRIMARY OBJECTIVES:
- To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different single low doses of rasburicase followed by allopurinol in 2 treatment arms.
SECONDARY OBJECTIVES:
- To estimate the proportion of patients requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL on day 2 through day 6.
II. To identify differential characteristics of the patients who do not respond to treatment.
III. To measure the area under the plasma uric acid concentration-time curve (AUC) from baseline (day 1) to day 7, time to plasma uric acid level less than or equal to 7.5mg/dL.
IV. To evaluate the rate of patients requiring hemodialysis (HD) V. To evaluate the safety of low single-doses of rasburicase. VI. To evaluate the rate of patients expressing a doubling of serum creatinine.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive 1.5mg of rasburicase intravenously (IV) over 30 minutes on day 1* and allopurinol orally (PO) once daily (QD) on days 1-6.
ARM II: Patients receive 3 mg of rasburicase IV over 30 minutes on day 1* and allopurinol PO QD on days 1-6.
NOTE: *Patients with serum uric acid >= 7.5mg/dl also receive rasburicase IV on days 2-3.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (1.5mg rasburicase) | Experimental | Drug: rasburicase, Drug: allopurinolPatients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6. |
| Arm II (3 mg rasburicase) | Experimental | Drug: rasburicase, Drug: allopurinolPatients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) status of 0-3
- Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS)
- Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by:
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Key exclusion criteria (6 listed)
- History of asthma
- History of severe or life threatening atopic allergy
- Hypersensitivity to uricases
- Known prior sensitivity to allopurinol
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
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 |
|---|---|---|
| rasburicaseAlso: Elitek, NK-631, recombinant urate oxidaseGiven IV | Drug | Arm I (1.5mg rasburicase), Arm II (3 mg rasburicase) |
| allopurinolAlso: 4'-HPP, ALLO, ZyloprimGiven PO | Drug | Arm I (1.5mg rasburicase), Arm II (3 mg rasburicase) |
Primary outcome
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
Time frame: Within 24 hours of rasburicase treatment
The proportion of patients able to achieve and/or maintain a uric acid level =< 7.5mg/dL for each treatment arm.
5 secondary outcomes
Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL
Time frame: Up to day 7
Baseline White Blood Cell Count by Response
Time frame: Up to day 7
Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7
Time frame: Up to day 7
Safety of Low Single-doses of Rasburicase.
Time frame: up to day 7
Number of Patients Experiencing a Doubling of Serum Creatinine
Time frame: up to day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eunice Wang, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rasburicase and allopurinol in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Roswell Park Cancer Institute at 1 site in United States.
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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Jan 2018. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL (time frame: Within 24 hours of rasburicase treatment). 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 9 Jan 2018.