CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 133 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00658814
NCT00658814Phase 2Active
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted Apr 15, 2008·Updated May 29, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia and 13 related conditions. Active but no longer recruiting, targeting 133 participants across 177 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute 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
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2013
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.2 years ago

Interventions

Azacitidinedrug

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

Gemtuzumab Ozogamicindrug

Given IV