Study Description
Screening
Study Centers
Contact/Consent
Chronic Myelogenous Leukemia (CML)
Chronic myelogenous leukemia (CML) is a cancer of the blood and bone marrow. All blood cells are made by stem cells in the bone marrow, which is the spongy tissue inside your bones. There are 3 types of blood cells: red cells, which carry oxygen to all the tissues in the body; white cells, which fight infection; and platelets, which allow the blood to clot to help stop bleeding when a blood vessel is damaged. In CML, the stem cells in the bone marrow make too many white blood cells, some of which never mature. These immature white blood cells collect in the bone marrow and blood. Eventually, the extra white blood cells crowd out the healthy red cells and platelets and interfere with the functioning of other organs. This causes the symptoms of CML.
Novartis is seeking people to participate in a clinical trial(s) testing the safety
and effectiveness of Novartis products. Novartis recommends that you consult your
doctor before participating in a clinical trial.
How to use this system:
The purpose of this system is to help connect interested study participants with clinical
research centers. The following is a brief outline explaining the main steps involved in
using this system. Please note that every step in this process is optional.
1. Select a clinical trial that you feel best suits your (or the participant's)
health condition.
2. Answer the screening questions to see if you (or the participant) meet
the preliminary qualifications for
the study. The answers to these questions
are not retained by this system.
3. Select a study center to contact for additional information about the
clinical trial.
4. Set up an account and agree to the terms of use for this system.
5. Submit your information to the study center you selected.
6. The study center may contact you and may ask more questions about your
(or the participant's) eligibility
for the study. The study center may invite you
(and the participant if applicable) to travel to the study center
for additional screening tests. Novartis cannot guarantee that you
will be contacted by the study center.
7. If you are eligible to participate in the study, then you will be required
to sign an
informed consent before enrolling in the study. An informed consent
is provided to you to help you understand the clinical trial, the nature of
the medical treatment (if any),
procedures and known risks involved, before you agree to participate in the study.
For more information about clinical trial participation, click here. Also, for additional information
about how Novartis helps to protect the privacy of the personal information that you provide to us, please
see the Novartis Privacy Policy.
Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits
your (or the participant's) condition.
Newly diagnosed Philadelphia chromosome positive CML Study - CAMN107A2303
The purpose of this clinical research study is to determine if two doses of the investigational drug nilotinib are safe and effective when compared to imatinib mesylate (Gleevec®) in newly diagnosed patients with Philadelphia chromosome positive (Ph+) Chronic Myelogenous Leukemia (CML). An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: The duration of the study is approximately 5 years until participants experience disease progression or develop an intolerance of the study treatment.
Protocol Number: CAMN107A2303
Chronic Myelogenous Leukemia (CML) Study CAMN107AUS09
The purpose of this clinical trial is to determine if the study drug, nilotinib (Tasigna®), is safe and has beneficial effects in people who have chronic myelogenous leukemia (CML) in the chronic phase and a suboptimal molecular response to imatinib (Gleevec®). Nilotinib (Tasigna®), is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic-phase and accelerated-phase Philadelphia chromosome positive (Ph+) CML in adult patients who are resistant or intolerant to prior treatment including imatinib (Gleevec®).
Trial phase: Phase 2
Participation Duration: Participants will be taking the study drug daily for up to 5 years on this study. They will be required to return to the study doctor’s office at regular intervals so that their condition can be monitored and routine blood tests and safety evaluation can be carried out.
Protocol Number: CAMN107AUS09
|