Clinical trial NCT00882102
Conditions: Acute Myelogenous Leukemia Myelodysplastic Syndrome
Keywords: Acute Myelogenous Leukemia High-Risk Myelodysplastic Syndrome AML MDS Leukemia Decitabine Gemtuzumab Ozogamicin Dacogen Mylotarg
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-04-01; Completion date: 2012-08-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

Gemtuzumab ozogamicin is designed to attach to Sialic acid-binding Ig-like lectin 3 (CD33), a certain protein that is often found in leukemia cells, causing them to die.

Decitabine is designed to damage the Deoxyribonucleic acid (DNA) (the genetic material) of cells, which may cause cancer cells to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive decitabine through a needle in your vein over 1 and 1/2 hours on Days 1-5 of each cycle. You will also receive gemtuzumab ozogamicin by vein over about 1 hour after you receive decitabine on Day 5 of each 4-8 week cycle.

During Cycle 1 only, if a bone marrow test done 2 weeks after you receive your first study drug treatment shows abnormal leukemia cells, you will receive another treatment with decitabine by vein over 1 and 1/2 hours for 5 days.

Gemtuzumab may cause allergic reactions, nausea, and vomiting. To help decrease the risk of such side effects, you will receive Benadryl (diphenhydramine), acetaminophen, meperidine, and hydrocortisone. You may receive these drugs by vein, or by mouth on each of the days you get gemtuzumab ozogamicin.

Study Visits:

At every study visit, you will be asked if you have experienced side effects and to list any drugs you may be taking.

During Cycle 1, blood (about 2 teaspoons) will be drawn at least 1 time each week for routine tests. If the doctor thinks it is necessary, you may be asked to have additional blood drawn.

On Day 1 of every cycle, your performance status will be recorded and your vital signs will be measured.

On Days 1-5 of Cycle 1, your vital signs will be measured.

Between Days 12 and 16 of Cycle 1, you will have a bone marrow aspirate if you have a diagnosis of AML or high-risk MDS to check the status of the disease. This test may be delayed if your doctor does not think you are in remission.

During Cycles 2-3, blood (about 2 teaspoons) will be drawn for routine tests at least 2 times each month.

On Day 1 of Cycles 2 and beyond, you will have a physical exam, including measurement of your vital signs.

During Cycles 4 and beyond, blood (about 2 teaspoons) will be drawn for routine tests at least 1 time each month.

If the doctor thinks it is necessary, you will have a bone marrow aspirate every 1-3 months to check the status of the disease.

You should tell the study doctor about all drugs and supplements you are taking while you are on this study.

Length of Study:

You may receive the combination of decitabine and gemtuzumab ozogamicin for up to 6 cycles. After this, if your doctor thinks it is in your best interest, you may continue to receive decitabine alone for up to 24 cycles. During this part of study, your performance status will be recorded, you will have a physical exam, and your vital signs will be measured on Day 1 of each cycle. Blood (about 2 teaspoons) will be drawn for tests once a month. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study drug(s).

Long-Term Follow-up:

Once you are off study, you will have follow-up visits every month for up to 2 years. At these visits, blood (about 2 teaspoons) will be drawn for routine tests.

This is an investigational study. Gemtuzumab ozogamicin is FDA approved and commercially available for the treatment of AML that has come back after treatment in patients over the age of 65 years. Decitabine is FDA approved and commercially available for the treatment of MDS. The use of gemtuzumab ozogamicin and decitabine in combination is investigational.

Up to 100 participants will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.

Arms: arm 1: Decitabine 20 mg/m\^2 by vein (IV) over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m\^2 by vein on day 5.
Interventions: intervention 1: Decitabine intervention 2: Gemtuzumab ozogamicin
Intervention descriptions: intervention 1: Decitabine 20 mg/m\^2 IV over 1-1/2 hours daily for 5 days. intervention 2: Gemtuzumab ozogamicin 3 mg/m\^2 IV on day 5.

Protocol documents: