Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Decitabine

Antimetabolites

Enzyme Inhibitors

Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.

Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.

Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.

Eltrombopag

Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.

Courtney DiNardo, MD

The goal of this clinical research study is to learn if eltrombopag given in combination with decitabine can help to control advanced MDS. The safety of this study drug combination will also be studied.

Study Drug Administration:

Each cycle is 28 days.

If you are found to be eligible to take part in this study, you will receive decitabine by vein over 1 hour on Days 1-5 of each cycle.

You will also take eltrombopag capsules by mouth 1 time every day of each cycle. You should take it on an empty stomach (1 hour before a meal or 2 hours after a meal) with 8 ounces (1 cup) of water.

Do not eat calcium-rich foods (such as dairy products and juices with added calcium), or take other drugs (such as antacids) or supplements containing iron, calcium, aluminum, magnesium, selenium, and/or zinc for 4 hours before or 4 hours after taking eltrombopag.

If a dose of eltrombopag is vomited, you should not make it up or re-take it on the same day. If the morning dose is missed, it may be taken up until 5:00 PM on the same day.

Study Visits:

On Day 1 of each cycle:

* You will have a physical exam.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.

On Days 8, 15, and 22 of Cycle 1 only, blood (about 2-3 teaspoons) will be drawn for routine tests.

If the doctor thinks it is needed, on Day 1 of Cycles 2-4, then every 3 cycles (Cycles 7, 10, 13, and so on), you will also have a bone marrow aspirate/biopsy to check the status of the disease and for cytogenetic testing.

If the doctor thinks it is needed, once each week blood (about 2-3 teaspoons) will be drawn for routine tests.

End-of-Treatment Visit:

Within 5 days of your last dose of study drug, you will come to the clinic for an end-of-treatment visit. The following procedures will be performed:

* You will have a physical exam.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.
* You will have a bone marrow aspirate/biopsy to check the status of the disease and for cytogenetic testing.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-up Visit:

About 28 days after your last dose of study drugs, you will come to the clinic for a follow-up visit. The following procedures will be performed:

* You will have a physical exam.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.

This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Decitabine is FDA approved for the treatment of MDS and is commercially available. The combination of eltrombopag and decitabine to treat MDS is investigational.

Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS)

Phase II Study of Eltrombopag in Combination With Decitabine in Subjects With Advanced Myelodysplastic Syndrome

The primary endpoint is the overall response rate (ORR) based on the IWG-2006 criteria, which includes complete remission (CR), partial remission (PR), and hematologic improvement (HI).

GlaxoSmithKline

M.D. Anderson Cancer Center

Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.

Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.

Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.

Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.

Eltrombopag + Decitabine

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Courtney DiNardo, MD/Associate Professor

One participant was not evaluable for response.

Overall Response Rate (ORR)

Overall Study

Immune System Diseases

Thrombocytopenia

Lymphoma

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Lymphocytic Leukemia

Starting dose 75 mg by mouth (PO) daily for 28 day cycle.

Starting dose 75 mg by mouth (PO) daily for 28 day cycle

William G. Wierda, MD, PHD, BS

The goal of this clinical research study is to learn if eltrombopag can help to increase the number of platelets in patients with CLL. The safety of this drug will also be studied.

The Study Drug:

When the number of platelets in your body gets too low, it can cause bleeding, which may cause serious health problems and/or prevent you from receiving chemotherapy. Eltrombopag is designed to act like a protein in your body that helps make platelets. This may help increase your platelet counts.

Study Drug Administration:

You will take pills of the study drug by mouth 1 time each day on an empty stomach (1 hour before or 2 hours after a meal). You should take the pills with 1 cup (8 ounces) of water. You should wait at least 4 hours between taking eltrombopag and eating foods with calcium (dairy products and/or juices with added calcium) or taking drugs/supplements with iron, calcium, aluminum, magnesium, selenium and/or zinc. Other drugs may also affect eltrombopag. Be sure to tell your doctor about any drugs and/or supplements you may be taking.

During your study visits, your doctor will check your platelet counts to see if they improve. If they do not improve, your dose of study drug may be increased. Your doctor will instruct you on each dose of eltrombopag you should take.

Do not take more than 1 dose of eltrombopag on any one day. If you forget to take a dose, you should skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Study Visits:

Each study "cycle" will be 28 days.

Each week during Cycle 1, then every 2 weeks during Cycles 2 and 3:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any bleeding that may have occurred since the last study visit.
* Blood (about 1 tablespoon) will be drawn for routine tests.

On Day 1 (+/- 7 days) of Cycles 4 and beyond:

* You will have a physical exam.
* You will be asked about any bleeding that may have occurred since the last study visit.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will also have a bone marrow aspirate/biopsy to check the status of the disease and to check your platelet counts. This test will only be performed every 3 cycles.

Length of Study Participation:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if you require other treatment for CLL or if intolerable side effects occur.

Follow-Up:

After you stop taking eltrombopag for any reason, your platelet counts may drop. This may increase your risk of bleeding. Blood (about 1 tablespoon) will be drawn each week for 4 weeks to check your platelet counts.

This is an investigational study. Eltrombopag is FDA approved and commercially available for use in chronic immune thrombocytopenic purpura (ITP - severe bleeding due to platelet destruction by the immune system). The use of this drug in patients with CLL is investigational.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

A Phase II Trial of Eltrombopag for Patients With Chronic Lymphocytic Leukemia (CLL) and Thrombocytopenia

Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from \<20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with \>20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks.

The number of months from start of treatment to CLL progression, requiring leukemia treatment. Disease Progression (PD) is defined as a \>/= 50% increase in at least one of the following in responding participants: \>/= 2 lymph nodes (on 2 exams 2 weeks apart), liver or spleen (below costal margin) , or absolute number of circulating lymphocytes (\>/= 10L/ul).

Starting dose 75 mg by mouth (PO) daily for 28 day cycle.

Eltrombopag: Starting dose 75 mg by mouth (PO) daily for 28 day cycle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS)	NCT02010645	Leukemia	Eltrombopag Decitabine	18 Years -	M.D. Anderson Cancer Center
Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)	NCT01168921	CLL Leukemia	Eltrombopag	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for promacta

Every month we try and update this database with for promacta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for promacta

Every month we try and update this database with for promacta cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for promacta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.