Advertisement

Topics

Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

2014-08-27 03:17:32 | BioPortfolio

Summary

The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

Description

The Study Drugs Clofarabine is designed to interfere with the growth and development of cancer cells.

Idarubicin is designed to cause breaks in DNA (the genetic material of cells) of cancer cells and interfere with their growth and development.

Cytarabine is designed to insert itself into DNA of cancer cells and stop the DNA from repairing itself.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs (blood pressure, breathing rate, heart rate, and temperature).

- You will be asked about any other drugs you may be taking.

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You will have either an echocardiogram or a multiple gated acquisition (MUGA) scan to check your heart function.

- You will have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) or urine pregnancy test.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drug combination over 1 or 2 "Induction Cycles" of treatment. Whether or not you receive a second Induction Cycle depends on the disease's response to the first Induction Cycle. Each Induction Cycle will last about 4-6 weeks, depending on your reaction to the study drugs. During each Induction -Cycle, you will receive the study drugs by the following schedule:

- Clofarabine, by vein, over 1-2 hours on Days 1-5.

- Cytarabine, by vein, over 2-3 hours on Days 1-5.

- Idarubicin, by vein, over about 30-60 minutes on Days 1-3.

If the disease shows a response to the treatment during the Induction Cycle(s), you may continue to receive up to 6 "Consolidation Cycles" of treatment. Each Consolidation Cycle will last about 3-7 weeks, depending on your reaction to the study drugs. During each Consolidation Cycle, you will receive the study drugs by the following schedule:

- Clofarabine, by vein, over 1-2 hours on Days 1-3.

- Cytarabine, by vein, over 2-3 hours on Days 1-3.

- Idarubicin, by vein, over 30-60 minutes on Days 1-2.

Study Visits:

On Day 1 of every cycle:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 1-2 teaspoons) will be drawn for routine tests.

Throughout the study, you will have blood and bone marrow tests to check the status of the disease and to help the doctor decide if you need additional cycles of treatment. Blood (about 2 tablespoons each time) will be drawn 2 times each week for routine tests during the Induction Cycles. This blood will also be drawn every week during the Consolidation Cycles.

About 3 weeks after you first receive the study drugs, you will have a bone marrow aspirate to check the status of the disease. After that, you will have a bone marrow aspirate every 2 weeks (or more often if your doctor thinks it is needed). However, if the routine blood tests show that there is still leukemia present, these bone marrow samples may not need to be collected.

You will need to stay in Houston for up to the first 5 weeks of treatment. After that, you will need to return to Houston to receive treatment, but you can have check-up visits and blood tests with your local doctor in between treatments.

Length of Study You will be able to receive the study drugs for up to 8 cycles (a maximum of 2 induction cycles and 6 consolidation cycles). You will be taken off study if the disease gets worse or you experience any intolerable side effects.

Follow-up Visits:

After you have stopped taking the study drug, blood (about 1 tablespoon each time) will be drawn 1 time each month for 2 years to check the status of the disease. After 2 years, this blood will be drawn every 3-6 months. If the doctor thinks it is needed, you will also have a physical exam every 6 months.

Within 8 weeks after you have stopped taking the study drug, you will also have an echocardiogram or a MUGA scan to check your heart function.

This is an investigational study. Cytarabine and idarubicin are both FDA approved and commercially available for the treatment of patients with AML. Clofarabine is FDA approved and commercially available for the treatment of patients with ALL. The use of this drug combination for the treatment of AML is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia

Intervention

Clofarabine, Idarubicin, Cytarabine

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:32-0400

Clinical Trials [2295 Associated Clinical Trials listed on BioPortfolio]

Clofarabine Combinations in Relapsed/Refractory AML, MDS and Myeloid Blast Phase CML

The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine...

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help c...

Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stoppin...

Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute l...

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Bevacizumab may stop the gr...

PubMed Articles [6917 Associated PubMed Articles listed on BioPortfolio]

Similar incidence of typhlitis in patients receiving various doses of daunorubicin or idarubicin as induction for acute myeloid leukemia.

The current standard of care for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) is an anthracycline plus cytarabine. Both anthracyclines and cytarabine have been associate...

Efficacy and safety of IA regimen containing different doses of idarubicin in de-novo acute myeloid leukemia for adult patients.

Objective: To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m(2), 10 mg/m(2) or 12 mg/m(2) as induction chemotherapy for adult patients with de-novo acute myel...

Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicine for acute myeloid leukemia in elderly patients.

The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) can induce high complete remission rates with acceptable toxicity in elderly patients with acute myeloid leukemia (AML). We pres...

Final results of a phase 2, open-label study of indisulam, idarubicin, and cytarabine in patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

Indisulam possesses anticancer properties through down-regulation of various cell-cycle checkpoint molecules, thereby blocking the phosphorylation of retinoblastoma protein and inducing p53 and p21. I...

Myeloid neoplasms with t(12;22)(p13;q12)/MN1-EVT6: a systematic review of 12 cases.

t(12;22)(p13;q12) is a rare but recurrent chromosomal abnormality involving the ETS transcription factor ETV6 and meningioma 1 (MN1) genes. In this study, we analyzed the clinical, cytogenetic, and mo...

Medical and Biotech [MESH] Definitions

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

More From BioPortfolio on "Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...


Searches Linking to this Trial