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Acute Myeloid LeukemiaPhase 2NCT00079482

Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

A Phase 2 study testing CEP-701, high-dose cytarabine and Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) in people with Acute Myeloid Leukemia, run by Cephalon at 81 sites in 13 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 purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CEP-701, high-dose cytarabine and Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
81 sitesin 13 countries
Study dates
Oct 2003to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • cytological confirmation of AML;
  • relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days;
  • confirmation of FLT-3 activating mutation positive status after point of initial relapse;
  • aged 18 years or older;
  • written informed consent;
  • ability to understand and comply with study restrictions;
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  • no comorbid conditions that would limit life expectancy to less than 3 months;
  • ECOG Performance Score of 0, 1,or 2;
  • women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry

Who cannot join

  • bilirubin > 2x ULN;
  • ALT/AST > 3x ULN;
  • serum creatinine > 1.5 mg/dL;
  • resting ejection fraction of left ventricle l < 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC];
  • untreated or progressive infection;
  • any physical or psychiatric cdtn that may compromise participation in the study;
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  • known CNS involvement with AML;
  • any previous treatment with a FLT-3 inhibitor;
  • requires current treatment for HIV with protease inhibitors;
  • active GI ulceration or bleeding;
  • use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment

Trial locations and contacts

81 sites in 13 countries.

81 sites in 13 countries

United States34 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Univeristy of Maryland Medicine - Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Johns Hopkins

    Baltimore, Maryland, 21231

  • St. Francis Cancer Care Services

    Beech Grove, Indiana, 46107

  • University of Alabama

    Birmingham, Alabama, 35294

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Hospital

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute Wayne State University

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Cancer Pavillion

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC/Norris Cancer Center

    Los Angeles, California, 90033

  • ACORN-Central Georgia Hematology/Oncology

    Macon, Georgia, 31201

  • ACORN-The West Clinic

    Memphis, Tennessee, 38120

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Presbyterian

    New York, New York, 10021

  • University of Nebraska

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • The Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo-Scottsdale

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • LSU Shreveport

    Shreveport, Louisiana, 71103

  • Washington University

    St Louis, Missouri, 63110

  • Stanford Medical Center

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33606

Other trials in United States

Poland10 sites

  • Call For Information

    Bialystok, 15276

  • Call For Information

    Gdansk, 80952

  • Call For Information

    Katowice, 40032

  • Call For Information

    Krakow, 31501

  • Call For Information

    Lodz, 93510

  • Call For Information

    Lublin, 20022

  • Call For Information

    Poznan, 60569

  • Call For Information

    Warsaw, 02097

  • Call For Information

    Warsaw, 02776

  • Call For Information

    Wroclaw, 50369

Other trials in Poland

Australia7 sites

  • Call For Information

    Adelaide, South Australia, 5000

  • Call For Information

    Fitzroy, Victoria, 3065

  • Call for Information

    Herston, Queensland, 4029

  • Call For Information

    Melbourne, Victoria, 3004

  • Call For Information

    Perth, Western Australia, 6000

  • Call For Information

    South Brisbane, Queensland, 4101

  • Call For Information

    Sydney, New South Wales, 2065

Other trials in Australia

Germany6 sites

  • Call For Information

    Chemnitz, 09113

  • Call For Information

    Dresden, 01307

  • Call For Information

    Frankfurt, 60590

  • Call For Information

    Heidelberg, 69120

  • Call For Information

    Münster, 48129

  • Call For Information

    Stuttgart, 70376

Other trials in Germany

Italy4 sites

  • Call For Information

    Bologna, 41038

  • Call For Information

    Roma, 00133

  • Call For Information

    Roma, 00161

  • Call For Information

    Turin, 10043

Other trials in Italy

Russia4 sites

  • Call For Information

    Moscow, 125167

  • Call For Information

    Novosibirsk, 630099

  • Call For Information

    Saint Petersburg, 197022

  • Call For Information

    Saint Petersburg, 197110

Other trials in Russia

Ukraine4 sites

  • Call For Information

    Cherkassy, 18009

  • Call For Information

    Kiev, 03115

  • Call For Information

    Kiev, 04112

  • Call For Information

    Lviv, 79044

Other trials in Ukraine

Israel3 sites

  • Call For Information

    Haifa, 31096

  • Call For Information

    Petah Tikva, 49100

  • Call For Information

    Tel HaShomer, 52621

Other trials in Israel

Canada2 sites

  • CHA Hospital Enfant-Jesus

    Québec, Quebec, G1J1Z4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G2M9

Other trials in Canada

Romania2 sites

  • Call For Information

    Bucharest, 030171

  • Call For Information

    Iași, 700111

Other trials in Romania

Spain2 sites

  • Call For Information

    Barcelona, 08041

  • Call For Information

    Valencia, 46009

Other trials in Spain

Sweden2 sites

  • Call For Information

    Lund, SE-22185

  • Call For Information

    Stockholm, SE-17176

Other trials in Sweden

New Zealand1 site

  • Call For Information

    Auckland, Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

Read the detailed description

Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

Being tested
CEP-701, high-dose cytarabine, Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Keywords
AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • CEP-701Drug

    Also called lestaurtinib

  • high-dose cytarabineDrug

    Also called HiDAC

    Chemotherapy

  • Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)Drug

    Also called MEC

    Chemotherapy

Study groups in NCT00079482
Study groupRoleWhat they receive
1Active comparatorInduction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC.
Receives: Drug: CEP-701; Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
2Active comparatorInduction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC.
Receives: Drug: CEP-701; Drug: high-dose cytarabine

What is being measured

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

  1. Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery.

    Measured: 113 days

Secondary outcomes (1)

  1. - overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity

    Measured: 113 days

Timeline

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

  1. First posted10 Mar 2004 (estimated)
  2. Study startOct 2003
  3. Primary completionMar 2009
  4. Study completionJan 2010

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
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079482
Sponsor's protocol ID
C701a/204/ON/US
Status last verified
Jul 2016
First submitted
8 Mar 2004
Last updated
21 Jul 2016
Results posted
No

Publications

  • Levis M, Ravandi F, Wang ES, Baer MR, Perl A, Coutre S, Erba H, Stuart RK, Baccarani M, Cripe LD, Tallman MS, Meloni G, Godley LA, Langston AA, Amadori S, Lewis ID, Nagler A, Stone R, Yee K, Advani A, Douer D, Wiktor-Jedrzejczak W, Juliusson G, Litzow MR, Petersdorf S, Sanz M, Kantarjian HM, Sato T, Tremmel L, Bensen-Kennedy DM, Small D, Smith BD. Results from a randomized trial of salvage chemotherapy followed by lestaurtinib for patients with FLT3 mutant AML in first relapse. Blood. 2011 Mar 24;117(12):3294-301. doi: 10.1182/blood-2010-08-301796. Epub 2011 Jan 26.

    PubMed 21270442

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CEP-701, high-dose cytarabine and Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) in people with Acute Myeloid Leukemia, run by Cephalon at 81 sites in 13 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 9 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: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Poland, Australia, Germany, Italy and 8 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery. (time frame: 113 days). 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 NCT00079482, 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 21 Jul 2016.

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