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LeukemiaPhase 2NCT00005962

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

A Phase 2 study testing sargramostim, cyclophosphamide and cytarabine in people with Leukemia, run by Eastern Cooperative Oncology Group at 65 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Leukemia
What is being tested?
sargramostim, cyclophosphamide and cytarabine
How many people
Not given
Where
65 sitesin 3 countries
Study dates
4 Oct 2000to Jun 2007
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven acute myelogenous leukemia of one of the following types:
  • Acute myeloblastic leukemia (FAB type M0, M1, or M2)
  • Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned
  • Acute myelomonocytic leukemia (FAB type M4)
  • Acute monocytic leukemia (FAB type M5)
  • Acute erythroleukemia (FAB type M6)
  • Acute megakaryocytic leukemia (FAB type M7)
  • Must meet 1 of the following criteria:
  • Relapse less than 6 months after first complete remission (CR)
  • Relapse 6-12 months after first CR
  • Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course)
  • Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration)
  • Second or greater relapse
  • No relapse greater than 1 year after achieving first CR
  • Blast cells must be CD33 positive
  • Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL*
  • SGOT less than 2 times upper limit of normal* NOTE: *Unless due to leukemia infiltration

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • See Chemotherapy
  • No myocardial infarction within the past 3 months
  • No significant congestive heart failure
  • No significant cardiac arrhythmia
  • Cardiac ejection fraction normal by MUGA scan or echocardiogram
  • Resting ejection fraction at least 50% or at least 5% increase with exercise
  • Shortening fraction at least 24% or normal by echocardiogram

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No concurrent organ damage or other medical problems that would precludestudy therapy
  • No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection
  • No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal
  • No other active tumor that would interfere with study therapy or increase risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior gemtuzumab ozogamicin

Chemotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • No prior daunorubicin liposomal or topotecan
  • Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate
  • At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy
  • Prior hydroxyurea allowed within 4 weeks prior to beginning study
  • Hydroxyurea must be discontinued at least 24 hours prior to beginning study

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy

Surgery:

  • Not specified

Trial locations and contacts

65 sites in 3 countries.

65 sites in 3 countries

United States62 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611-3013

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Veterans Affairs Medical Center - Gainsville

    Gainesville, Florida, 32608-1197

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa, 52242-1009

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Veterans Affairs Medical Center - Omaha

    Omaha, Nebraska, 68105

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • MBCCOP-Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Puerto Rico2 sites

  • MBCCOP - San Juan

    San Juan, 00927-5800

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

South Africa1 site

  • Pretoria Academic Hospitals

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia.

PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.

Read the detailed description

OBJECTIVES:

  • Compare the rates of complete response (CR) and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide, cytarabine, and topotecan.
  • Compare the toxicities of these 3 regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status (relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) vs second or greater relapse).

  • Induction: Patients are randomized to 1 of 3 treatment arms:
  • Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5.
  • Arm II: Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours (beginning immediately after completion of daunorubicin liposomal infusion) on days 1-4.
  • Arm III: Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3, cytarabine IV over 2 hours (beginning immediately after completion of cyclophosphamide infusion) on days 2-6, and topotecan IV continuously on days 2-6.
  • Consolidation: Patients who achieve complete remission (CR) receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR. Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50% preconsolidation. All patients receive sargramostim (GM-CSF) IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover.

Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until death.

PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this study within 2 years.

Conditions
Leukemia
Being tested
sargramostim, cyclophosphamide, cytarabine, gemtuzumab ozogamicin, liposomal daunorubicin citrate
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 promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Promyelocytic, 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 posted5 Nov 2003 (estimated)
  2. Study start4 Oct 2000
  3. Primary completionOct 2005
  4. Study completionJun 2007

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005962
Sponsor's protocol ID
CDR0000067944
Other IDs
E-4999
Status last verified
Jun 2023
First submitted
5 Jul 2000
Last updated
22 Jun 2023
Results posted
No

Publications

  • Litzow MR, Othus M, Cripe LD, Gore SD, Lazarus HM, Lee SJ, Bennett JM, Paietta EM, Dewald GW, Rowe JM, Tallman MS; Eastern Cooperative Oncology Group Leukemia Committee. Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group. Br J Haematol. 2010 Jan;148(2):217-25. doi: 10.1111/j.1365-2141.2009.07917.x. Epub 2009 Oct 5.

    PubMed 19804455

  • Litzow MR, Goloubeva O, Rowe J, et al.: A randomized phase II trial of gemtuzumab ozogamicin vs. liposomal daunorubicin vs. cyclophosphamide plus topotecan, each combined with intermediate dose Ara-C for the treatment of patients with relapsed or refractory acute myelogenous leukemia . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2359, 2003.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sargramostim, cyclophosphamide and cytarabine in people with Leukemia, run by Eastern Cooperative Oncology Group at 65 sites in 3 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Puerto Rico, South Africa. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005962, which also lists 2 linked publications.

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 22 Jun 2023.

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