Track topics on Twitter Track topics that are important to you
The goal of this clinical research study is to learn if starting arsenic trioxide (ATO) therapy on Day 1 rather than Day 10 is more effective in treating patients with newly-diagnosed acute promyelocytic leukemia (APL).
All-trans retinoic acid (ATRA) and ATO are designed to cause the APL cells to mature and function normally. Gemtuzumab ozogamycin (GO) is designed to kill APL cells.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 5 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children (or you may have a urine pregnancy test). To be eligible to take part in this study, the pregnancy test must be negative. You will have a bone marrow aspirate to confirm the APL diagnosis. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
If you are found to be eligible to take part in this study, you will begin induction. During induction, you will receive ATRA, by mouth starting on Day 1. You will also receive ATO through a needle in your vein over 2 hours starting on Day 1. You will continue receiving the drugs every day until your bone marrow no longer shows APL cells.
If you had a high white blood cell count at screening, you will receive GO through a needle in your vein over 30 minutes on Day 1.
During induction, blood (about 1-3 tablespoons) will be drawn every day during Week 1, and then 2 times a week after that. This blood will be drawn for routine tests.
If you achieve a complete remission during the induction phase, you will continue to the maintenance phase. During the maintenance phase, you will receive ATO by vein over 2 hours Monday-Friday for 4 weeks. After the 4 weeks of receiving the study drug, you will have a 4-week period "off" (when no study drug is given). ATRA is given by mouth every day for 2 weeks. This 2 weeks is followed by 2 additional weeks when no study drug will be given. You will continue to take ATRA until treatment with ATO is complete.
During maintenance, blood (about 1-3 tablespoons) will be drawn before every 4-week cycle of ATO, and then every week for routine tests. You will also have an ECG before every 4 week cycle when you take ATO.
If you do not achieve a complete remission during induction you will be taken off study.
If at any point during the study your white blood cell count rises above 30,000, you will receive GO by vein over 30 minutes.
You will remain in the hospital for about the first 7 days of induction. After that, you must remain in Houston for the next 3-4 weeks. Once in the maintenance phase, you may be treated at home, but must return to M. D. Anderson for study visits.
After maintenance is complete, you will have follow-up visits for an additional 2 years. If at any time during the active study or follow-up the disease gets worse or intolerable side effects occur, you will be taken off the study.
If you had a low or high white blood cell count when you joined the study, you will have follow-up visits every 3 months for 2 years. At these visits, blood (about 1 tablespoon) will be drawn for routine tests and you will have a bone marrow aspirate.
This is an investigational study. ATRA and ATO are FDA approved and commercially available. However, their use in this study and in this combination is considered investigational. GO is also FDA approved and commercially available. Its use in APL patients is investigational. Up to 80 patients will take part in the study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute Promyelocytic Leukemia
All-Trans Retinoic Acid (ATRA), Arsenic Trioxide (ATO), Gemtuzumab Ozogamicin (GO), Theophylline
The University of Texas M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:41:05-0400
The goal of this clinical research study is to learn if the combination of all-trans retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control APL. ...
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an in...
This is a Phase 1 open label study of the dose and duration of an orally administered LSD1 inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (...
The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, o...
This is an Italian, single center, randomized, phase II study. ATRA (all-trans retinoic acid) and derivatives (retinoids) are promising anticancer agents and exert their anti-proliferative...
Patients with high-risk acute promyelocytic leukemia (APL) have inferior outcomes compared with patients with low-risk APL, predominantly due to higher risk of early mortality related to hemorrhage. T...
The vast majority of acute promyelocytic leukemia (APL) is characterized with a specific chromosomal translocation t (15, 17) (q22, q21), which fuses PML-RARα leading to a good response to all-trans ...
Strategies using oral arsenic trioxide (As O ) are efficacious in relapsed acute promyelocytic leukemia (APL), but they have not been examined in newly diagnosed cases.
Realgar-Indigo naturalis formula(RIF)is an oral form of arsenic developed for treatment of acute promyelocytic leukemia (APL). We retrospectively evaluated the efficacy and safety of a novel RIF combi...
In acute promyelocytic leukemia (APL), normal retinoid signaling is disrupted by an abnormal PML-RARα fusion oncoprotein, leading to a block in cell differentiation. Therapeutic concentrations of all...
A cytochrome P450 enzyme that resides in the ENDOPLASMIC RETICULUM. It catalyzes the conversion of trans-RETINOIC ACID to 4-hydroxyretinoic acid.
Proteins in the nucleus or cytoplasm that specifically bind RETINOIC ACID or RETINOL and trigger changes in the behavior of cells. Retinoic acid receptors, like steroid receptors, are ligand-activated transcription regulators. Several types have been recognized.
Apolipoproteins and lipocalins that occur in HIGH-DENSITY LIPOPROTEINS. They bind or transport lipids in the blood including sphingosine-1-phosphate, MYRISTIC ACID; STEARIC ACIDS; and ALL-TRANS RETINOIC ACID.
A subtype of RETINOIC ACID RECEPTORS that are specific for 9-cis-retinoic acid which function as nuclear TRANSCRIPTION FACTORS that regulate multiple signalling pathways.
A metalloflavoprotein enzyme involved the metabolism of VITAMIN A, this enzyme catalyzes the oxidation of RETINAL to RETINOIC ACID, using both NAD+ and FAD coenzymes. It also acts on both the 11-trans- and 13-cis-forms of RETINAL.
Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...