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LeukemiaPhase 3NCT00006045

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

A Phase 3 study testing lintuzumab, cytarabine and etoposide in people with Leukemia, run by Facet Biotech at 59 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
lintuzumab, cytarabine and etoposide
How many people
Not given
Where
59 sitesin 7 countries
Study dates
Mar 2000to not given
Phase
Phase 3
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

DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder All FAB subtypes except M3 Must meet one of the following three criteria: First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline No high dose cytarabine (no cumulative dose greater than 3 g/m2) First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: First BMT At least 100 days but less than 1 year posttransplantation At least 25% cellularity of the bone marrow Previous BMT included full hematopoietic recovery, defined by all of the following: Hemoglobin at least 10 g/dL (without transfusion) Platelet count at least 100,000/mm3 (without transfusion) Absolute neutrophil count at least 1,500/mm3 No transplantation candidates Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration) SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) Renal: Creatinine less than 2.0 mg/dL (unless related to AML) Cardiovascular: Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study HIV negative No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation Chemotherapy: See Disease Characteristics For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed

Trial locations and contacts

59 sites in 7 countries.

59 sites in 7 countries

United States40 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Nevada Cancer Center

    Las Vegas, Nevada, 89106

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • West Clinic, P.C.

    Memphis, Tennessee, 38117

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2516

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • St. Joseph Hospital - Orange

    Orange, California, 92613-5600

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Sidney Kimmel Cancer Center

    San Diego, California, 92121

  • Louisiana State University School of Medicine

    Shreveport, Louisiana, 71130-3932

  • Washington University Barnard Cancer Center

    St Louis, Missouri, 63110

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • North Mississippi Hematology and Oncology Associates, Ltd.

    Tupelo, Mississippi, 38801

  • New York Medical College

    Valhalla, New York, 10595

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

Germany5 sites

  • Universitaetsklinikum Benjamin Franklin

    Berlin, D-12200

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen

    Munich, D-81675

  • Westfaelische Wilhelms-Universitaet

    Münster, DOH-4-8149

  • University of Rostock

    Rostock, 18057

Other trials in Germany

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Science Center

    Halifax, Nova Scotia, B3H 2Y9

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

United Kingdom4 sites

  • Addenbrooke's NHS Trust

    Cambridge, England, CB2 2QQ

  • Royal Free Hospital

    Hampstead, London, England, NW3 2QG

  • Leeds Teaching Hospital Trust

    Leeds, England, LS1 3EX

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

Other trials in United Kingdom

Belgium3 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

France2 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • CHRU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Netherlands1 site

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination With Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

Read the detailed description

OBJECTIVES: I. Compare the efficacy, safety, pharmacokinetics, and immunogenicity of mitoxantrone, etoposide, and cytarabine (MEC) with or without monoclonal antibody HuG1-M195 in patients with refractory or relapsed acute myelogenous leukemia.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over) and duration of previous complete remission (CR) (0-6 vs 7-12 months). All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours, mitoxantrone IV over a maximum of 20 minutes, and etoposide IV over 1-2 hours on days 1-6. On day 5 of induction, patients are randomized to one of two treatment arms: Arm I: Patients receive day 6 of induction chemotherapy. Patients then receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 6-9 or 7-10. Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses (courses 1 and 2) in the absence of disease progression or unacceptable toxicity. During course 1, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression (regimen failure (RF)) are taken off study. Patients without RF are assigned to one of two consolidation groups based on response: Group A (CR): Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2, and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4. Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation. Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8. Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses (courses 3 and 4). During course 3, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Group B (partial remission (PR), hematologic improvement (HI), or stable disease (SD)): Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy. Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4. Treatment repeats every month for 8 additional courses (courses 5-12). Arm II: Patients receive day 6 of induction chemotherapy. Patients receive no MOAB HuM195 during the entire study. Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response: Group C (CR): Patients receive consolidation chemotherapy as in group A. Group D (PR, HI, or SD): Patients receive no further treatment. Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302. Patients are followed every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 200 patients (100 per arm) will be accrued for this study.

Conditions
Leukemia
Being tested
lintuzumab, cytarabine, etoposide, mitoxantrone hydrochloride
Keywords
recurrent adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), secondary acute myeloid leukemia, adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Megakaryoblastic, Acute

What participants receive

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

Timeline

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

  1. First posted13 Apr 2004 (estimated)
  2. Study startMar 2000

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 3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006045
Sponsor's protocol ID
CDR0000068061
Other IDs
PDL-195-301, MSKCC-00029, UCLA-9910050, NCI-G00-1819
Status last verified
Feb 2010
First submitted
5 Jul 2000
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lintuzumab, cytarabine and etoposide in people with Leukemia, run by Facet Biotech at 59 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Germany, Canada, United Kingdom, Belgium and 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006045.

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 6 Nov 2013.

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