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Acute Myeloid LeukemiaPhase 2NCT00788892

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

A Phase 2 study testing CPX-351, Cytarabine and Daunorubicin in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 28 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CPX-351, Cytarabine and Daunorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
28 sitesin 2 countries
Study dates
Oct 2008to Dec 2011
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 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥60 and <76 years at the time of diagnosis of AML
  • Pathological confirmation of AML
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Able to adhere to the study visit schedule and other protocol requirements
  • Laboratory values fulfilling the following:
  • Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
  • Cardiac ejection fraction > 50% by echocardiography or MUGA scan

Who cannot join

  • Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible)
  • Prior treatment for AML; only hydroxyurea is permitted (see below)
  • Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
  • Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
  • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
  • Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
Show all 12Show fewer
  • Clinical evidence of active CNS leukemia
  • Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
  • Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
  • Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
  • Hypersensitivity to cytarabine, daunorubicin or liposomal products
  • History of Wilson's disease or other copper-related disorder

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

United States25 sites

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • St.Francis Hospital

    Beech Grove, Indiana, 46107

  • Blumenthal Cancer Center/Mecklenburg Medical Group

    Charlotte, North Carolina, 28204

  • Robert H.Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612-3861

  • Jewish Hospital

    Cincinnati, Ohio, 45236

  • Northern New Jersey Cancer Associates

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79415

  • North Shore University Hospital

    Manhasset, New York, 11020

  • Froedlert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Weil Cornell Medical Center

    New York, New York, 10021

  • University of Pittsburg Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • Cancer Therapy and Research Center at the University of Texas

    San Antonio, Texas, 78229

  • University of California Medical Center

    San Francisco, California, 94143

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Arizona Cancer Center

    Tucson, Arizona, 85724-5024

  • New York Medical College, Division of Oncology

    Valhalla, New York, 10595

Other trials in United States

Canada3 sites

  • Queen Elisabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • BC Cancer Research Center

    Vancouver, British Columbia, V5Z 1L3

Other trials in Canada

About this study

Official title: Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.

The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

Read the detailed description

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Being tested
CPX-351, Cytarabine, Daunorubicin
Keywords
Acute, Myeloid, Leukemia, elderly, Newly, Diagnosed
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Disease

What participants receive

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

Study groups in NCT00788892
Study groupRoleWhat they receive
Arm A: CPX-351ExperimentalFirst induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
Receives: Drug: CPX-351
Arm B: Cytarabine + DaunorubicinActive comparatorFirst induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Receives: Drug: Cytarabine; Drug: Daunorubicin

What is being measured

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

  1. Number of Participants With Complete Remission

    Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.

    Measured: Within 6 weeks of the last induction treatment

Secondary outcomes (5)

  1. Remission Duration/Time to Remission

    Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.

    Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.

    Measured: Following achievement of CR over the study period

  2. Event Free Survival

    Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.

    Measured: Up to 1 year from randomization

  3. Overall Survival Rate at 1 Year

    Survival defined as the time from randomization to death.

    Measured: 1 year

  4. Rate of Stem Cell Transplant

    The rate of patients who underwent stem cell transplant.

    Measured: Up to 1 year

  5. Aplasia Rate

    Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.

    Measured: Day 14 (1st Induction)

Timeline

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

  1. First posted11 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJun 2010
  4. Study completionDec 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788892
Sponsor's protocol ID
CLTR0308-204
Status last verified
Oct 2017
First submitted
10 Nov 2008
Last updated
12 Jan 2018
Data monitoring committee
Yes

Publications

  • Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. doi: 10.1182/blood-2013-12-540971. Epub 2014 Mar 31.

    PubMed 24687088

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPX-351, Cytarabine and Daunorubicin in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 28 sites in 2 countries.

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 7 inclusion and 12 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: finished, as of the sponsor's last update on 12 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 28 sites in United States, Canada. 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 12 Jan 2018). 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?

Number of Participants With Complete Remission (time frame: Within 6 weeks of the last induction treatment). 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 NCT00788892, which also lists 1 linked publication.

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 12 Jan 2018.

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