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A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)


- Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients
with relapsed acute myeloid leukemia.

- Determine the frequency and severity of toxic effects of this regimen in CD33-positive

- Determine, preliminarily, the prognostic significance of drug resistance phenotype,
cytogenetics, and molecular genetic characteristics of patients treated with this

OUTLINE: This is a multicenter study.

- Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1
and 8 and cytarabine IV continuously over days 1-7.

- Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow,
B1 peripheral blood, and C1 extramedullary disease status receive one course of
gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28

Inclusion Criteria


- Histologically confirmed acute myeloid leukemia (AML)

- FAB M1-2 or M4-7

- No blastic transformation of chronic myelogenous leukemia

- In first relapse after prior complete response

- Patients who relapsed after autologous or allogeneic bone marrow or peripheral
blood stem cell transplantation are not eligible

- CD33 positive

- Prior myelodysplastic syndromes or secondary AML allowed

- Concurrent enrollment on SWOG-9007 (cytogenetics protocol)

- No clinical or documented CNS involvement with AML



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- WBC no greater than 30,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 1.5 times ULN


- Not specified


- No unstable cardiac arrhythmias

- No unstable angina


- HIV negative

- No other malignancy within the past 5 years except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Adequately treated stage I or II cancer currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- See Disease Characteristics

- No prior gemtuzumab ozogamicin for AML


- Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

- Not specified


- Not specified


- Not specified


- At least 4 weeks since prior investigational agents and recovered

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

After induction therapy is completed

Safety Issue:


Principal Investigator

John E. Godwin, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

October 2010

Related Keywords:

  • Leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute erythroid leukemia (M6)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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