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Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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), Blastic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, de Novo Myelodysplastic Syndromes, Noncontiguous Stage II Adult Burkitt Lymphoma, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Stage I Adult Burkitt Lymphoma, Stage III Adult Burkitt Lymphoma, Stage IV Adult Burkitt Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy


PRIMARY OBJECTIVES:

I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2
different low doses of rasburicase followed by allopurinol in 2 treatment arms.

SECONDARY OBJECTIVES:

I. 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.


Inclusion Criteria:



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

- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Probability of obtaining a uric acid level =< 7.5mg/dL

Outcome Description:

The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.

Outcome Time Frame:

Within 24 hours of rasburicase treatment

Safety Issue:

No

Principal Investigator

Meir Wetzler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 197711

NCT ID:

NCT01564277

Start Date:

September 2011

Completion Date:

Related Keywords:

  • 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)
  • Blastic Phase Chronic Myelogenous Leukemia
  • Contiguous Stage II Adult Burkitt Lymphoma
  • de Novo Myelodysplastic Syndromes
  • Noncontiguous Stage II Adult Burkitt Lymphoma
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Stage I Adult Burkitt Lymphoma
  • Stage III Adult Burkitt Lymphoma
  • Stage IV Adult Burkitt Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Blast Crisis
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263