A Phase 2 interventional study of Azacitidine and Gemtuzumab Ozogamicin in Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia and Adult Acute Monoblastic Leukemia, sponsored by National Cancer Institute (NCI). Active, not recruiting at 177 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
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 (QD) 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 (with azacitidine given SC only).
MAINTENANCE THERAPY: Patients receive azacitidine SC 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 (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA.
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 133 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:
=\< 2.0 x institutional (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML
HIV-positive patients must meet the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
See Detailed Description
Drug: Azacitidine · Drug: Gemtuzumab Ozogamicin
Given IV or SC during induction; given SC during consolidation and maintenance
Also known as: 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza
Given IV
Also known as: Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676
Complete Response
Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Time frame: Up to 60 days
30-Day Survival
Patients surviving more than 30 days after study registration
Time frame: 30 days
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 5 years
Relapse-free Survival
Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
Time frame: Up to 5 years
| Milestone | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| Started | 83 | 59 |
| Eligible | 82 | 57 |
| Eligible and began protocol therapy | 79 | 54 |
| Completed | 75 | 41 |
| Not completed | 8 | 18 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Progression/relapse | 0 | 1 |
| Withdrew: Death | 1 | 4 |
| Withdrew: Not protocol specified | 2 | 4 |
| Withdrew: Not eligible | 1 | 2 |
| Milestone | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| Started | 24 | 13 |
| Eligible | 22 | 11 |
| Completed | 22 | 10 |
| Not completed | 2 | 3 |
| Withdrew: Not protocol specified | 0 | 1 |
| Withdrew: Not eligible | 2 | 2 |
| Milestone | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| Started | 20 | 8 |
| Eligible | 19 | 8 |
| Completed | 17 | 7 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Not protocol specified | 1 | 0 |
| Withdrew: Not eligible | 1 | 0 |
Only adverse events that are possibly, probably or definitely related to study drug are reported.
| Participants | Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy |
|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | 5 | 0 | 0 |
| AST, SGOT | 4 | 0 | 0 |
| Adult respiratory distress syndrome (ARDS) | 1 | 0 | 0 |
| Albumin, serum-low (hypoalbuminemia) | 5 | 1 | 0 |
| Anorexia | 5 | 1 | 0 |
| Bilirubin (hyperbilirubinemia) | 3 | 0 | 0 |
| Calcium, serum-low (hypocalcemia) | 6 | 0 | 0 |
| Carbon monoxide diffusion capacity (DL(co)) | 1 | 0 | 0 |
| Cardiac Arrhythmia-Atrial fibrilation | 1 | 0 | 0 |
| Cardiac General-cardiopulmonary disease | 1 | 0 | 0 |
| Cardiac General-Chest Pain | 1 | 0 | 0 |
| Cardiac troponin I (cTnI) | 1 | 0 | 0 |
| Cardiac-ischemia/infarction | 1 | 0 | 0 |
| Conduction abnormality NOS | 1 | 0 | 0 |
| Confusion | 1 | 0 | 0 |
| Constipation | 2 | 0 | 0 |
| Cytokine release syndrome/acute infusion reaction | 1 | 0 | 0 |
| Death - Disease progression NOS | 1 | 0 | 0 |
| Death - Multi-organ failure | 2 | 0 | 0 |
| Death not associated with CTCAE term - Death NOS | 1 | 0 | 0 |
| Dehydration | 1 | 0 | 0 |
| Diarrhea | 2 | 0 | 0 |
| Dyspnea (shortness of breath) | 5 | 1 | 2 |
| Edema: limb | 1 | 0 | 0 |
| Fatigue (asthenia, lethargy, malaise) | 18 | 1 | 1 |
| Febrile neutropenia | 50 | 0 | 0 |
| Glucose, serum-high (hyperglycemia) | 10 | 3 | 2 |
| Hemoglobin | 73 | 1 | 1 |
| Hemorrhage, CNS | 1 | 0 | 0 |
| Hemorrhage, GI - Stomach | 1 | 0 | 0 |
| Hemorrhage, GI - Upper GI NOS | 1 | 0 | 0 |
| Hemorrhage/Bleeding-platelets and red blood cells | 1 | 0 | 0 |
| Hepatobiliary/Pancreas-venoocclusive disease | 1 | 0 | 0 |
| Hypertension | 1 | 0 | 0 |
| Hypotension | 2 | 0 | 0 |
| Hypoxia | 4 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 16 | 0 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 2 | 1 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 3 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Kidney | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 8 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 2 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 6 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 3 | 0 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 2 | 1 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 | 0 | 1 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 | 0 | 0 |
| Infection with unknown ANC - Blood | 1 | 0 | 0 |
| Infection with unknown ANC - Lung (pneumonia) | 1 | 0 | 0 |
| Infection with unknown ANC - Skin (cellulitis) | 1 | 0 | 0 |
| Infection-Aspirgillosis | 1 | 0 | 0 |
| Infection-bacteremia | 1 | 0 | 0 |
| Left ventricular systolic dysfunction | 1 | 0 | 0 |
| Leukocytes (total WBC) | 80 | 18 | 6 |
| Liver dysfunction/failure (clinical) | 0 | 1 | 0 |
| Lymphopenia | 23 | 0 | 1 |
| Mood alteration - depression | 2 | 0 | 0 |
| Mucositis/stomatitis (functional/symp) - Oral cav | 1 | 0 | 0 |
| Muscle weakness, not d/t neuropathy - body/general | 4 | 0 | 0 |
| Neutrophils/granulocytes (ANC/AGC) | 85 | 21 | 10 |
| Pain - Cardiac/heart | 2 | 0 | 0 |
| Petechiae/purpura (hemorrhage into skin or mucosa) | 1 | 0 | 0 |
| Phosphate, serum-low (hypophosphatemia) | 4 | 0 | 0 |
| Platelets | 85 | 12 | 3 |
| Pleural effusion (non-malignant) | 1 | 0 | 0 |
| Pneumonitis/pulmonary infiltrates | 1 | 0 | 0 |
| Potassium, serum-low (hypokalemia) | 5 | 0 | 0 |
| Pulmonary/Upper Respiratory-pulmonary edema | 2 | 0 | 0 |
| Rash/desquamation | 1 | 0 | 0 |
| SVT and nodal arrhythmia - Atrial fibrillation | 2 | 0 | 0 |
| SVT and nodal arrhythmia - SVT tachycardia | 1 | 0 | 0 |
| Sodium, serum-low (hyponatremia) | 5 | 0 | 0 |
| Sudden death | 1 | 0 | 0 |
| Thrombosis/thrombus/embolism | 2 | 0 | 0 |
Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
| percentage of participants | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| Complete Response | 44 (33 to 56) | 35 (23 to 49) |
Patients surviving more than 30 days after study registration
| percentage of participants | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| 30-Day Survival | 92 (84 to 97) | 87 (75 to 95) |
Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
| months | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|
| Relapse-free Survival | 8 (5 to 13) | 7 (6 to 12) |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Remission Induction Chemotherapy | — | 55/133 (41.4%) | 130/133 (97.7%) |
| Consolidation Therapy | — | 1/32 (3.1%) | 32/32 (100%) |
| Maintenance Therapy | — | 3/27 (11.1%) | 26/27 (96.3%) |
| Event | Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy |
|---|---|---|---|
| Death - Disease progression NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 12/133 | 0/32 | 0/27 |
| Febrile neutropeniaBlood and lymphatic system disorders | 10/133 | 0/32 | 0/27 |
| Inf (clin/microbio) w/Gr 3-4 neuts - BloodInfections and infestations | 7/133 | 0/32 | 0/27 |
| Inf (clin/microbio) w/Gr 3-4 neuts - LungInfections and infestations | 7/133 | 0/32 | 0/27 |
| HypotensionVascular disorders | 6/133 | 0/32 | 0/27 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 5/133 | 0/32 | 1/27 |
| Inf w/normal ANC or Gr 1-2 neutrophils - LungInfections and infestations | 0/133 | 0/32 | 1/27 |
| FractureInjury, poisoning and procedural complications | 0/133 | 0/32 | 1/27 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 2/133 | 0/32 | 1/27 |
| Pain - BackMusculoskeletal and connective tissue disorders | 0/133 | 0/32 | 1/27 |
| Event | Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy |
|---|---|---|---|
| PlateletsInvestigations | 100/133 | 25/32 | 11/27 |
| HemoglobinBlood and lymphatic system disorders | 98/133 | 20/32 | 15/27 |
| Leukocytes (total WBC)Investigations | 87/133 | 23/32 | 16/27 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 91/133 | 23/32 | 14/27 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 69/133 | 18/32 | 19/27 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 81/133 | 15/32 | 11/27 |
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 63/133 | 13/32 | 9/27 |
| Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders | 58/133 | 6/32 | 5/27 |
| NauseaGastrointestinal disorders | 56/133 | 5/32 | 5/27 |
| ConstipationGastrointestinal disorders | 47/133 | 6/32 | 10/27 |
Eligible patients who began protocol therapy
| Age, Continuous(years) | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total |
|---|---|---|---|
| Median | 71.2 (60.5 to 88.7) | 76 (70.3 to 87) | 73.4 (60.5 to 88.7) |
| Sex: Female, Male(Participants) | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total |
|---|---|---|---|
| Female | 30 | 21 | 51 |
| Male | 49 | 33 | 82 |
| Race/Ethnicity, Customized(participants) | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Black or African American | 1 | 4 | 5 |
| White | 77 | 50 | 127 |
| Hispanic(participants) | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total |
|---|---|---|---|
| Yes | 3 | 1 | 4 |
| No | 64 | 50 | 114 |
| Unknown | 12 | 3 | 15 |
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Ran from Dec 2008 to primary completion in Jun 2013, 54 months.
Results were first posted in Jan 2014, 7 months after primary completion.
Of 385 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's 54 months is below that.
Counting every sponsor, half of 442 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azacitidine · Gemtuzumab
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