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A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia.

Phase 2
60 Years
Open (Enrolling)
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), 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), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia.


I. To test whether outcomes of patients of age 60 or older with previously untreated non-M3
acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to
warrant phase III investigation.

II. To estimate the frequency and severity of toxicities of this regimen in the good- and
poor-risk groups of patients.

III. To investigate in a preliminary manner the disease-free survival of patients who
achieve complete remission and receive post-remission therapy on this study.

IV. To investigate in a preliminary manner the cytogenetic response rates of patients
treated with this regimen.

V. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter
and global methylation changes, and multidrug resistance on overall survival and response to
azacitidine plus gemtuzumab ozogamicin therapy.

OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR
Zubrod performance status [PS] 0-1] vs poor [≥ 70 years of age AND Zubrod PS 2-3]).

REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40
minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2
hours on day 8. Patients with residual leukemia (blast count ≥ 5%) receive a second course
of induction therapy beginning between days 15-29. Patients achieving complete remission
(CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to
receive consolidation therapy.

CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin
as in induction therapy.

MAINTENANCE THERAPY: Patients receive azacitidine IV over 10-40 minutes or subcutaneously on
days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic
studies at baseline, remission, and relapse or progression. Marrow and blood samples are
submitted to correlatives studies and submitted to SWOG ALL/CLL/CML Repository in Seattle,

After completion of study therapy, patients are followed every 2 months for 2 years, every 3
months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Inclusion Criteria:

- Morphologically confirmed diagnosis of acute myeloidleukemia (AML)

- No acute promyelocytic leukemia (FAB M3)

- No blastic transformation of chronic myelogenous leukemia

- Patients with a history of prior myelodysplastic syndrome (MDS) are eligible
according to the following criteria:

- No prior treatment of MDS with AML induction-type chemotherapy or high-dose
chemotherapy with hematopoietic stem cell support

- Prior cytarabine allowed if dose < 100 mg/m^2/day

- Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide,
and signal transduction inhibitors for treatment of MDS allowed

- No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin

- At least 30 days since prior therapy for MDS and recovered

- Must be registered on SWOG-S9910

- No CNS involvement

- Zubrod performance status 0-3

- Total bilirubin ≤ 2.0 times upper limit of normal (ULN) (unless the elevation is
believed to be due to hepatic infiltration by AML)

- Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia
secondary to Gilbert syndrome or hemolysis allowed

- AST or ALT ≤ 2.0 times ULN (unless the elevation is believed to be due to hepatic
infiltration by AML)

- Serum creatinine ≤ 1.5 times ULN

- LVEF ≥ 40% by MUGA or ECHO AND no clinical evidence of congestive heart failure
within the past 56 days

- No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV-positive patients must meet the following criteria:

- No history of AIDS-defining events

- CD4 cells ≥ 500/mm^3

- Viral load of < 50 copies HIV mRNA/mm^3 if on cART or < 25,000 copiesHIV mRNA if
not on cART

- No zidovudine or stavudine as part of cART

- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer or any diagnosis of malignancy made within the past 2 years of which
there is no clinically evident cancer, and for which the patient has completed all
chemotherapy and radiotherapy at least 6 months prior to study registration

- Concurrent hormonal therapy allowed

- At least 6 months since prior chemotherapy or radiotherapy

- No prior systemic chemotherapy for acute leukemiaexcept hydroxyurea

- Prior hydroxyurea to control high WBC count allowed

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Probability of achieving CR or CRp

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Sucha Nand

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • 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)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Secondary Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic



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