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Acute Lymphoblastic LeukemiaPhase 2NCT02257684

A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)

A Phase 2 study testing pegcrisantaspase in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals at 43 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL). Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
pegcrisantaspase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
43 sitesUnited States
Study dates
Sep 2014to Jan 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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Have a diagnosis of ALL/LBL
  • Be > 1 to ≤ 21 years of age at study enrollment
  • Have had a ≥ Grade 2 allergic reaction (Common Terminology Criteria for Adverse Events [CTCAE] v4.03) to pegaspargase
  • Have ≥ 1 dose(s) of pegaspargase remaining in his/her treatment plan
  • Have a documented SAA level that is below the limit of quantitation per the analytical method.
  • Subjects must have, in the opinion of the investigator, fully recovered from prior allergic reaction to pegaspargase. Subjects must have completed antihistamine, epinephrine, and/or corticosteroid treatment for the allergic reaction ≥ 24 hours prior to pegcrisantaspase administration.
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  • Subjects must have a performance status corresponding to:
  • Karnofsky ≥ 50 (for subjects > 16 years of age)
  • Lansky ≥ 50 (for subjects ≤ 16 years of age)
  • Adequate Renal Function Defined as:
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or
  • A serum creatinine based on age/gender as follows:
  • Age Maximum Serum Creatinine (mg/dL) Male Female 1 to < 2 years 0.6 0.6 2 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4
  • ≥ 16 years 1.7 1.4
  • The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz \& Gauthier 1985) utilizing child length and stature data published by the CDC.
  • Adequate Liver Function defined as:
  • Bilirubin levels ≤ 2.5x ULN for age, and Direct (conjugated) Bilirubin < 0.5 mg/dLSGPT (ALT) ≤ 225 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Subjects who are sexually active must agree to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months prior to baseline), and progestin implant or injection.
  • Able to understand and to sign a written informed consent. All subjects and/or their parent or a legally authorized representative must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Who cannot join

  • Have previously received Erwinia asparaginase
  • Are receiving another investigational agent or will receive an investigational agent in subsequent phases of protocol therapy that include asparaginase
  • Have a history of ≥ Grade 3 pancreatitis (CTCAE v4.03)
  • Prior history of a CNS thrombotic event or ≥ Grade 3 (CTCAE v4.03) thrombotic event, excluding catheter-associated clots
  • Prior history of asparaginase-associated ≥ Grade 3 (CTCAE v4.03) hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy
  • Blood triglyceride levels > 500 mg/dL or > 5.6 mmol/L
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  • Hyperglycemia requiring insulin therapy
  • QTc prolongation ≥ 550 msec
  • Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
  • Subjects who have any serious active disease or co-morbid medical condition (according to investigator's decision), or psychiatric illness that would prevent the subject from signing the informed consent form, assent form or informed consent form by parents, pending institutional requirements, or per investigator's opinion, would prevent the subject from completing one course of pegcrisantaspase.
  • Pregnant or lactating females or females of childbearing potential not willing to use an adequate method of birth control for the duration of the study. Female subjects who are lactating who do not agree to stop breast-feeding.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • C.S. Mott / University of Michigan

    Ann Arbor, Michigan, 48109-5718

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Dell Children's Medical Center

    Austin, Texas, 78723

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center, Levine Cancer Institute, Levine Children's Hospital

    Charlotte, North Carolina, 28203

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Wayne State University c/o Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Bi-Lo Charities Children's Cancer Center

    Greenville, South Carolina, 29681

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

  • Texas Children's Hospital / Baylor College of Medicine

    Houston, Texas, 77030

  • Riley Hospital for Children / Indiana University

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • Children's Mercy Hospital - Kansas City

    Kansas City, Missouri, 64108

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Miller Children's Hospital

    Long Beach, California, 9080

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027-6016

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202

  • Children's Hospital Central California

    Madera, California, 93636

  • University of Wisconsin / American Family Children's Hospital

    Madison, Wisconsin, 53792

  • Children's Hospital of Wisconsin / Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center - Fairview

    Minneaplois, Minnesota, 55455

  • Children's Hospitals & Clinics of Minnesota

    Minneapolis, Minnesota, 55404

  • Vanderbilt University Ingram Cancer Center

    Nashville, Tennessee, 37212

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040

  • Children's Hospital Main Campus

    New Orleans, Louisiana, 70118

  • Kaiser Permanente

    Oakland, California, 94611

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital & Medical Center of Omaha

    Omaha, Nebraska, 68114

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • UCSF Benioff Children's Hospital / UCSF Benioff Children's Hospital

    San Francisco, California, 94143

  • Seattle Children's Hospital

    Seatlle, Washington, 98105

  • Washington University School of Medicine

    St Louis, Missouri, 37212

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Children's National Medical Center Center for Cancer & Blood Disorders

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).

Read the detailed description

The purpose of the study was to assess the response rate in children and young adults with ALL/LBL and hypersensitivity to pegaspargase defined as the proportion of subjects having a serum asparaginase activity (SAA) level of ≥ 0.1 IU/mL 14 days following the first IV pegcrisantaspase dose in Course 1. Also, to assess the safety of IV pegcrisantaspase therapy in children and young adults with ALL/LBL with hypersensitivity to pegaspargase.

Being tested
pegcrisantaspase
Keywords
ALL, LBL
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegcrisantaspaseDrug

Study groups in NCT02257684
Study groupRoleWhat they receive
PegcrisantaspaseExperimentalNot described
Receives: Drug: pegcrisantaspase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1

    Measured: 15 days during Course 1

  2. The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.

    Measured: 1 Year

Secondary outcomes (3)

  1. The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.

    Measured: 14 Days

  2. The SAA Levels Over Time Following Repeated Administration in Children and Young Adults ALL/LBL and Hypersensitivity to Pegaspargase

    Measured: 30 Days

  3. The Immunogenicity of IV Pegcristaspase by Testing Anti-pegcrisantaspase and Anti-PEG Binding and Neutralizing Antibodies

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2015
  4. Study completionJan 2016

Why it stopped: Sponsor decision

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257684
Sponsor's protocol ID
13-011
Status last verified
Mar 2017
First submitted
22 Sep 2014
Last updated
4 Apr 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegcrisantaspase in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals at 43 sites 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 19 inclusion and 11 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites 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 23 Feb 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?

The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1 (time frame: 15 days during Course 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257684.

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 4 Apr 2017.

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