NCT01564277

Brief 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. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 8, 2017

Completed
Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

3.7 years

First QC Date

March 2, 2012

Results QC Date

October 2, 2017

Last Update Submit

December 11, 2017

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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 LeukemiaContiguous Stage II Adult Burkitt Lymphomade Novo Myelodysplastic SyndromesNoncontiguous Stage II Adult Burkitt LymphomaPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaStage I Adult Burkitt LymphomaStage III Adult Burkitt LymphomaStage IV Adult Burkitt LymphomaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Up to day 7

  • Baseline White Blood Cell Count by Response

    Up to day 7

  • Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7

    Up to day 7

  • Safety of Low Single-doses of Rasburicase.

    up to day 7

  • Number of Patients Experiencing a Doubling of Serum Creatinine

    up to day 6

Study Arms (2)

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.

Drug: rasburicaseDrug: 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.

Drug: rasburicaseDrug: allopurinol

Interventions

rasburicaseDRUG

Given IV

Also known as: Elitek, NK-631, recombinant urate oxidase
Arm I (1.5mg rasburicase)Arm II (3 mg rasburicase)
allopurinolDRUG

Given PO

Also known as: 4'-HPP, ALLO, Zyloprim
Arm I (1.5mg rasburicase)Arm II (3 mg rasburicase)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Congenital AbnormalitiesBlast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt Lymphoma

Interventions

rasburicasePeplomycinUrate OxidaseAllopurinol

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Intervention Hierarchy (Ancestors)

BleomycinGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsOxidoreductasesEnzymesEnzymes and CoenzymesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Administrator, Compliance - Clinical Research Services
Organization
Roswell Park Cancer Institute
716-845-2300

Study Officials

  • Eunice Wang, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 27, 2012

Study Start

September 29, 2011

Primary Completion

May 28, 2015

Study Completion

May 28, 2016

Last Updated

January 9, 2018

Results First Posted

December 8, 2017

Record last verified: 2017-12

Locations

US(1)