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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01889 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The safety of this treatment will also be studied.
Study Drugs:
Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the beginning of chemotherapy. A high level of uric acid results from TLS and can lead to kidney failure.
Allopurinol is designed to help block uric acid. It is the standard of care for helping to control increased uric acid levels caused by TLS.
Study Groups and Drug Administration:
Each cycle will last about 3 weeks.
If you are found to be eligible to take part in this study, you will receive rasburicase by vein over about 30 minutes on Day 1 of Cycle 1 (about 4 hours before you begin receiving chemotherapy). If the doctor thinks it is needed, you may also receive the drug on Days 2-5 of Cycle 1.
For Cycle 2, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. There is an equal chance of being assigned to either group:
Group B Participants: If your uric acid blood levels continue to increase in Cycle 2 and you show symptoms of tumor lysis syndrome, you may receive rasburicase as a single dose. If the doctor thinks it is needed, you may also receive 1 or more additional dose(s).
Study Visits:
On Day 1 of Cycle 1:
On Days 2-5 of Cycle 1:
At the end of both cycles, blood (about 1 teaspoon) will be drawn for antibody testing.
Length of Study:
You will receive drugs on this study for up to 2 cycles. You will be taken off study if intolerable side effects occur.
Your participation in the study will be over after the follow-up visit.
Follow-Up:
Three (3) months after the end of Cycle 2, blood (about 1 teaspoon) will be drawn for antibody testing.
This is an investigational study. Allopurinol is commercially available and FDA approved to treat TLS. Rasburicase is commercially available and FDA approved for treating TLS for 1 cycle in patients with leukemia, lymphoma, and solid tumor cancers who are receiving anti-cancer therapy. It is investigational to give rasburicase for 2 cycles.
Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasburicase Alone | Experimental | Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle). |
|
| Arm A (Rasburicase) | Experimental | Participants randomized to Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2. |
|
| Arm B (Allopurinol) | Experimental | Participants randomized to Allopurinol (300 mg/day) by vein each day on Days 1-5 of Cycle 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasburicase | Drug | Cycle 1: 3 mg/kg by vein on Day 1, plus as needed dosing (until day 5), during Cycle 1. Cycle 2 Arm A: 0.15 mg/kg by vein on Day 1 of Cycle 2, plus as needed dosing (until day 5), during Cycle 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome) | Number of participants (incidence) of LTLS in the two arms, as defined by the Cairo-Bishop criteria , during cycle 2. Cairo-Bishop criteria: Uric acid x ≥ 476 μmol/l or 25% increase from baseline Potassium x ≥ 6·0 mmol/l or 25% increase from baseline Phosphorous x ≥ 2·1 mmol/l (children), x ≥1·45 mmol/l (adults) or 25% increase from baseline Calcium x ≤ 1·75 mmol/l or 25% decrease from baseline Laboratory tumour lysis syndrome (LTLS) is defined as either a 25% change or level above or below normal, as defined above, for any two or more serum values of uric acid, potassium, phosphate, and calcium within 3d before or 7d after the initiation of chemotherapy. | Up to two 3-week cycles, 6 weeks |
| Number of Cycle 2 Participants Normalizing Uric Acid Levels (UAL) Within 24 Hours of Treatment | Number of participants with normalized UAL as determined by a uric acid blood test at either 24 hours. A uric acid blood test, also known as a serum uric acid measurement, determines how much uric acid is present in the blood where normal levels are 2.4-6.0 mg/dL (female) and 3.4-7.0 mg/dL (male). | Up to 24 hours of cycle 2 dose delivery |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saroj Vadhan-Raj, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Cycle 2 is the study cycle; of the 55 participants enrolled on study, 52 were treated in cycle 1 (rasburicase alone), and only 46 were randomized onto the two arms in the study cycle (cycle 2, Arm A: Rasburicase; Arm B: Allopurinol).
Recruitment Period: April 25, 2011 to September 10, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cycle 1: Rasburicase Alone | Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle). |
| FG001 | Cycle 2, Arm A: Rasburicase | Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2. |
| FG002 | Cycle 2, Arm B: Allopurinol | Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1: Rasburicase Alone Delivery |
|
| |||||||||||||||||||||
| Cycle 2: Randomization |
|
Of 55 enrolled on study, 52 participants were treated in Cycle 1 Rasburicase alone, only 46 randomized to Cycle 2 Arm A Rasburicase (21) and Arm B Allopurinol (25).
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| ID | Title | Description |
|---|---|---|
| BG000 | Rasburicase Alone | Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome) | Number of participants (incidence) of LTLS in the two arms, as defined by the Cairo-Bishop criteria , during cycle 2. Cairo-Bishop criteria: Uric acid x ≥ 476 μmol/l or 25% increase from baseline Potassium x ≥ 6·0 mmol/l or 25% increase from baseline Phosphorous x ≥ 2·1 mmol/l (children), x ≥1·45 mmol/l (adults) or 25% increase from baseline Calcium x ≤ 1·75 mmol/l or 25% decrease from baseline Laboratory tumour lysis syndrome (LTLS) is defined as either a 25% change or level above or below normal, as defined above, for any two or more serum values of uric acid, potassium, phosphate, and calcium within 3d before or 7d after the initiation of chemotherapy. | All 46 participants treated in randomized cycle 2 of study were included in analysis. | Posted | Count of Participants | Participants | Up to two 3-week cycles, 6 weeks |
|
Adverse events were captured before and after each cycle, up to 30 days from day 1 of the study drug and clinical assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cycle 1: Rasburicase Alone | Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saroj Vadhan, MD/Professor, Cytokine & Supportive Oncology | UT MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015275 | Tumor Lysis Syndrome |
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C469709 | rasburicase |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Allopurinol | Drug | Arm B: 300 mg/day by vein, as standard of care, over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle. |
|
|
| NOT COMPLETED |
|
| years |
|
| Age, Customized | Baseline age of participants randomized in Cycle 2. | Each row represents continuous age for each randomized arm in Cycle 2, Arm A Rasburicase (N=21) and Arm B Allopurinol (N=25), total 46. | Median | Full Range | years |
|
| Sex: Female, Male | Measure rows divide Cycle 1 (55) then those randomized to Cycle 2 Arm A (21) and Arm B (25). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) PS, Cycle 1 | Participant performance status (PS) using the ECOG scale which ranges from 0 to 4, with 0 being fully functional and asymptomatic, and 4 being bedridden. | Number | participants |
|
| ECOG PS, Cycle 2 | Row represents PS as defined above for each randomized arm in Cycle 2, Arm A (21) and Arm B (25), total 46. | Randomized arms in Cycle 2 Arm A (21) and Arm B (25). | Count of Participants | Participants |
|
| Tumor Lysis Syndrome (TLS) Risk | High risk: Hyperuricemia of malignancy (Uric acid level>7.5); or diagnosis aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, CML in blast crisis; high grade myelodysplastic syndrome only if >10% bone marrow blast involvement, aggressive treatment similar to acute myeloid leukemia (AML). Potential risk: Diagnosis aggressive lymphoma/leukemia (REAL classification) + 1/> criteria: lactate dehydrogenase (LDH) >2 x upper limit of normal (UNL); Stage III-IV disease; Stage I-II disease + 1/> lymph node/tumor >5 cm diameter. | Count of Participants | Participants |
|
| Baseline Plasma Uric Acid (PUA) | PUA determined by uric acid blood test. | Randomized Cycle 2 Arm A (21) and Arm B (25). | Count of Participants | Participants |
|
Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2. |
| OG001 | Arm B (Allopurinol) | Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2. |
|
|
| Primary | Number of Cycle 2 Participants Normalizing Uric Acid Levels (UAL) Within 24 Hours of Treatment | Number of participants with normalized UAL as determined by a uric acid blood test at either 24 hours. A uric acid blood test, also known as a serum uric acid measurement, determines how much uric acid is present in the blood where normal levels are 2.4-6.0 mg/dL (female) and 3.4-7.0 mg/dL (male). | One participant in Arm A missed one UA level assessment. | Posted | Count of Participants | Participants | Up to 24 hours of cycle 2 dose delivery |
|
|
|
| 0 |
| 52 |
| 3 |
| 52 |
| 38 |
| 52 |
| EG001 | Cycle 2: Arm A (Rasburicase) | Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2. | 1 | 21 | 1 | 21 | 12 | 21 |
| EG002 | Cycle 2: Arm B (Allopurinol) | Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2. | 1 | 25 | 1 | 25 | 17 | 25 |
| Methemoglobinemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D007951 | Leukemia, Myeloid |