A clinical trial is one of the final stages of a long and careful cancer research process. Studies are conducted with cancer patients to find out whether promising approaches to cancer diagnosis and treatment are safe and effective.
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in ways that result in reliable information about the drug, while protecting patients. Most clinical trials are classified into one of three phases (see below). In addition, after a treatment has been approved by the United States Food and Drug Administration (FDA) and is being marketed, the drug's manufacturer may study it further in a phase IV trial. The purpose of a phase IV trial is to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials.
PHASES OF CLINICAL TRIALS
Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often, and in what dose, which is both safe and effective. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
Source: National Cancer Institute
The Lymphoma Research Foundation (LRF) provides a Clinical Trials Information Service to increase awareness about investigational treatments for all types of lymphoma, including mantle cell lymphoma, that are currently being evaluated at cancer treatment centers nationwide. LRF does not provide medical advice or endorse specific treatments; however, upon request, the LRF Helpline staff will conduct a search for potential mantle cell lymphoma treatment trials based upon medical information provided by a patient.
Patients are strongly encouraged to discuss with their physician(s) the trial information provided by LRF. A patient’s healthcare team will be familiar with their medical history and can best evaluate all of the study criteria to determine if the clinical trial is appropriate for their patient.
People with mantle cell lymphoma interested in contacting the LRF Helpline to learn more about a clinical trial should be prepared to provide the following information, which is requested in order to perform a clinical trials search:
- Diagnosis (lymphoma subtype)
- Types of previous treatment (if any), the dates and the response
- Other medical diagnosis (i.e., another cancer, HIV, pregnancy)
- Geographic area willing to travel for treatment
Numerous mantle cell lymphoma clinical trials are currently being conducted at hospitals, cancer centers, and doctors' offices, often sponsored by the government, pharmaceutical companies, universities, and physician groups. The FDA, as well as the Institutional Review Board of the participating hospital or institution must approve each clinical trial phase. A patient’s decision to participate in a cancer clinical trial is an individual decision that should be made with their doctor after careful consideration of all of the potential risks and benefits. Note that patients may choose to discontinue participation in a clinical trial at any time.
For additional information on lymphoma clinical trials, please review the following LRF resources:
If you have questions, or would like assistance, call the Lymphoma Research Foundation Helpline at (800) 500-9976 or e-mail the Helpline staff directly.
Please note: LRF makes reasonable efforts to search publicly posted trials, but cannot guarantee that the clinical trial information provided are entirely comprehensive or that a patient will meet all eligibility criteria. Not all study sponsors post their clinical trial information on public databases, so there is no entirely comprehensive listing. Clinical trials information is updated frequently. LRF cannot be held responsible for any consequences or damages arising from the use of this information. This service is governed by the terms and conditions of the website.