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Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

NCT00658814 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-04-30

Study results available
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Summary

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Conditions

  • Acute Myeloid Leukemia
  • Adult Acute Megakaryoblastic Leukemia
  • Adult Acute Monoblastic Leukemia
  • Adult Acute Monocytic Leukemia
  • Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
  • Adult Acute Myeloid Leukemia With Maturation
  • Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1
  • Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A
  • Adult Acute Myeloid Leukemia Without Maturation
  • Adult Acute Myelomonocytic Leukemia
  • Adult Erythroleukemia
  • Adult Pure Erythroid Leukemia
  • Secondary Acute Myeloid Leukemia

Interventions

DRUG

Azacitidine

Given IV or SC during induction; given SC during consolidation and maintenance

DRUG

Gemtuzumab Ozogamicin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Sucha Nand · SWOG Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-01
Primary Completion
2013-06-01
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658814 on ClinicalTrials.gov