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Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsored by: Leukemia Research Fund
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005823
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.

PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
 Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: hydroxyurea
Drug: idarubicin
Drug: mitoxantrone hydrochloride
Drug: thioguanine
Drug: tretinoin
Drug: valspodar
 Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Daunorubicin hydrochloride Daunorubicin Mitoxantrone hydrochloride Mitoxantrone Hydroxyurea Etoposide phosphate Tretinoin Thioguanine Sdz psc 833
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over

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

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Response achievement [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity by WHO Toxicity Grading after each treatment course [ Designated as safety issue: Yes ]
  • Quality of life EORTC QLQ-C30 at 3 days, 1 month, 3 months, and 6 months from study entry [ Designated as safety issue: No ]
  • Resource use (use of blood products, antibiotics and days in hospital) after each treatment course [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: December 1998
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Acute myeloid leukemia (de novo or secondary) OR

  • Myelodysplastic syndrome

    • More than 10% myeloblasts in the bone marrow
    • Refractory anemia with excess blasts
    • Refractory anemia with excess blasts in transformation
    • Chronic myelomonocytic leukemia
  • No acute promyelocytic leukemia (FAB type M3)
  • No blastic phase chronic myeloid leukemia

PATIENT CHARACTERISTICS:

Age:

  • 60 and over (younger patients allowed if intensive chemotherapy not indicated)

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No liver function test ≥ 2 times normal (for non-intensive therapy arm)

Renal:

  • Not specified

Cardiovascular:

  • No myocardial infarction within past 6 months in patients receiving daunorubicin or PSC 833

Other:

  • No other concurrent active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy for leukemia

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005823

Locations
United Kingdom, England
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom, B15 2RR
University College Hospital
London, England, United Kingdom, WC1E 6AU
United Kingdom, Wales
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Leukemia Research Fund
Investigators
Study Chair: Alan K. Burnett, MD, FRCP The University of New South Wales
  More Information

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

Publications of Results:
Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24.
Burnett AK, Milligan DW, Prentice AG, et al.: Modification or dose or treatment duration has no impact on outcome of AML in older patients: preliminary results of the UK NCRI AML14 trial. [Abstract] Blood 106 (11): A-543, 2005.
Burnett AK, Milligan D, Prentice AG, et al.: Low dose Ara-C versus hydroxyurea with or without retinoid in older patients not considered fit for intensive chemotherapy: the UK NCRI AML14 trial. [Abstract] Blood 104 (11): A-872, 2004.
Pallis M, Truran L, Grundy M, et al.: P-Glycoprotein overexpresion and internal tandem duplications of FLT3 are characteristic of discrete populations of elderly AML patients. [Abstract] Blood 104 (11): A-196, 2004.

Other Publications:
Seedhouse CH, Grundy M, White P, Li Y, Fisher J, Yakunina D, Moorman AV, Hoy T, Russell N, Burnett A, Pallis M. Sequential Influences of Leukemia-Specific and Genetic Factors on P-Glycoprotein Expression in Blasts from 817 Patients Entered into the National Cancer Research Network Acute Myeloid Leukemia 14 and 15 Trials. Clin Cancer Res. 2007 Dec 1;13(23):7059-7066.
Burnett AK, Milligan D, Hills RK, et al.: Does all-transretinoic acid (ATRA) have a role in non-APL acute myeloid leukaemia? Results from 1666 patients in three MRC trials. [Abstract] Blood 104 (11): A-1794, 2004.

Study ID Numbers: CDR0000067831, LRF-AML14, EU-20016, ISRCTN62207270
Study First Received: June 2, 2000
Last Updated: July 26, 2008
ClinicalTrials.gov Identifier: NCT00005823  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated 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)
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
secondary acute myeloid leukemia
 de novo myelodysplastic syndromes
adult acute monocytic leukemia (M5b)
secondary myelodysplastic syndromes
adult acute minimally differentiated myeloid leukemia (M0)
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
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
Precancerous Conditions
Chronic myelogenous leukemia
Hydroxyurea
Chronic myelomonocytic leukemia
Refractory anemia
Acute myelomonocytic leukemia
Di Guglielmo's syndrome
Leukemia, Myeloid, Acute
Etoposide phosphate
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
 Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Etoposide
Acute myelocytic leukemia
Cytarabine
Myelodysplastic syndromes
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Thioguanine
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Myeloproliferative Disorders

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hematologic Agents
Antibiotics, Antineoplastic
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Syndrome
 Analgesics
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Antisickling Agents
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009



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