Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin Followed By High-Dose Cytarabine Followed By Either Gemtuzumab Ozogamicin or No Additional Therapy in Treating Patients With Previously Untreated De Novo Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085709

Purpose

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and 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 chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.

PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cytarabine Drug: daunorubicin hydrochloride Drug: filgrastim Drug: gemtuzumab ozogamicin Drug: sargramostim Procedure: observation	Phase III

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Filgrastim Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Sargramostim Granulocyte-macrophage colony-stimulating factor Gemtuzumab ozogamicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Induction complete remission rate [ Designated as safety issue: No ]

Estimated Enrollment:	684
Study Start Date:	July 2004
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Induction therapy Arm I: Experimental Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover.	Drug: cytarabine Given IV Drug: daunorubicin hydrochloride Given IV Drug: filgrastim Given IV or subcutaneously Drug: gemtuzumab ozogamicin Given IV Drug: sargramostim Given IV or subcutaneously
Induction Therapy Arm II: Active Comparator Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I.	Drug: cytarabine Given IV Drug: daunorubicin hydrochloride Given IV Drug: filgrastim Given IV or subcutaneously Drug: sargramostim Given IV or subcutaneously
Post-consolidation therapy Arm I: Experimental Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.	Drug: gemtuzumab ozogamicin Given IV
Post-consolidation therapy Arm II: No Intervention Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.	Procedure: observation No intervention

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy* within the past 14 days
- No M3 disease NOTE: *Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL
No blastic transformation of chronic myelogenous leukemia
No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)

PATIENT CHARACTERISTICS:

Age

18 to 60

Performance status

Zubrod 0-3

Life expectancy

Not specified

Hematopoietic

See Disease Characteristics

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
No known hepatitis B or C infection
No known liver disease

Renal

Not specified

Cardiovascular

LVEF ≥ 50% by MUGA or echocardiogram
No unstable cardiac arrhythmias
No unstable angina

Other

No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy
- Prior hydroxyurea to control high cell counts allowed
No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
Concurrent intrathecal chemotherapy allowed during induction therapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085709

Show 264 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:

Stephen H. Petersdorf, MD

Seattle Cancer Care Alliance

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000360812, SWOG-S0106
Study First Received:	June 14, 2004
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00085709
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated adult acute myeloid leukemia
adult acute eosinophilic leukemia
adult acute basophilic leukemia
adult acute monocytic leukemia (M5b)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)

adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Daunorubicin
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Antibodies, Monoclonal
Leukemia, Myelomonocytic, Acute

Leukemia
Antibodies
Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Acute monoblastic leukemia
Cytarabine
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents

Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009