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NCT00028899 · CITED IN SOURCE DOCUMENTS

Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2014-02-20

RATIONALE: Drugs used in chemotherapy work in 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 monoclonal antibody therapy with combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes * Relapsed (remission duration less than 1 year) OR * Failed induction (failed to achieve an initial complete response) * Patients with AML as a second malignant neoplasm allowed provided no other prior therapy for AML * M2 or M3 bone marrow aspirate at time of study entry * No Fanconi's anemia * No known CNS leukemia PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times normal * AST or ALT less than 2.5 times upper limit of normal * No history of veno-occlusive disease of the liver defined as weight increase of more than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after receipt of chemotherapy Renal: * Creatinine no greater than 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR * Equivalent GFR by institutional normal range Cardiovascular: * Shortening fraction more than 27% by echocardiogram or normal for institution OR * Ejection fraction more than 50% by MUGA Other: * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 180 days since prior hematopoietic stem cell transplantation Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
interventions
  1. name
    asparaginase
    type
    DRUG
  2. name
    cytarabine
    type
    DRUG
  3. name
    gemtuzumab ozogamicin
    type
    DRUG
  4. name
    mitoxantrone hydrochloride
    type
    DRUG
Study design
primary Purpose
TREATMENT
Enrollment
count
47
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Event Free Survival
    time Frame
    Length of study
secondary Outcomes
  1. description
    Toxicity will be monitored through study chair notification and end course reports
    measure
    Toxicity
  2. description
    The remission rate in each arm will be estimated by the proportion of patients who achieved remission among patients who received GMTZ at the MTD level.
    measure
    Remission Rate
    time Frame
    Length of study
  3. description
    The predictive value of the likelihood of leukemia blast cells to undergo apoptosis and drug resistance of leukemia blast cells will be assessed by logistic regression
    measure
    Prognostic Factor Analysis
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy work in 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 monoclonal antibody therapy with combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
detailed Description
OBJECTIVES: * Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination with conventional chemotherapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes. * Determine the efficacy of this regimen in these patients. * Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the efficacy of this regimen in these patients. * Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1 expression by leukemic blast cells with the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are assigned by cohort to 1 of 2 treatment regimens. * Regimen A: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4, mitoxantrone IV over 1 hour on days 3-6, and gemtuzumab ozogamicin IV over 2 hours on day 7. * Regimen B: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, asparaginase intramuscularly on days 2 and 9, and gemtuzumab ozogamicin IV over 2 hours on day 3. Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1.5 years.
Source references
references
  1. citation
    Aplenc R, Alonzo TA, Gerbing RB, Lange BJ, Hurwitz CA, Wells RJ, Bernstein I, Buckley P, Krimmel K, Smith FO, Sievers EL, Arceci RJ; Children's Oncology Group. Safety and efficacy of gemtuzumab ozogamicin in combination with chemotherapy for pediatric acute myeloid leukemia: a report from the Children's Oncology Group. J Clin Oncol. 2008 May 10;26(14):2390-3295. doi: 10.1200/JCO.2007.13.0096.
    pmid
    18467731
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        >Evidence (gemtuzumab ozogamicin with or without chemotherapy):</p> <div class="pdq-content-list"><ol id="_2009"><li>The COG <a href="/clinicaltrials/NCT00028899">AAML00P2 (NCT00028899)</a> study established the maximum tolerated dose (MTD) of gemtuzumab ozogamicin, when combined with mitoxantrone and high-dose cytarabi
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        zogamicin with or without chemotherapy):</p> <div class="pdq-content-list"><ol id="_2009"><li>The COG <a href="/clinicaltrials/NCT00028899">AAML00P2 (NCT00028899)</a> study established the maximum tolerated dose (MTD) of gemtuzumab ozogamicin, when combined with mitoxantrone and high-dose cytarabine, as 3 mg/m<span clas
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      source title
      Childhood Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 15, 2025
        datetime
        2025-04-15T12:00:00Z
        display
        April 15, 2025

    Preserved source evidence · Not medical advice