MANTLE CELL LYMPHOMA CLINICAL TRIAL PHASES

A new treatment must go through at least three trial phases before it becomes a standard therapy that is used in hospitals and clinics.

Each subsequent phase builds on information learned from the previous phase. Patients may be able to take part in different stages depending on their condition, type and stage of lymphoma, and the type of treatment, if any, they have already received.

PHASE I

The first phase of a clinical trial studies the best way to give a treatment and how much of it can be given safely. The treatment has been tested in a laboratory, but scientists need to see how it works with human patients.

This phase usually has the most risks; it is usually only offered to a small number of people who have not been helped by standard treatments. Patients are watched very carefully through the treatment.

PHASE II

Once a safe dose or way to give the therapy is established in Phase I, it is tested in Phase II. This phase looks at how effective the treatment may possibly be on the cancer.

This phase involves a larger number of patients than Phase I; focus not only on side effects of a new treatment but also on disease response.

PHASE III

When the treatment gets to Phase III, it is thought to be safe and have promising anti-mantle cell lymphoma activity. This phase tests the treatment on a large number of patients to confirm the results suggested in the first two phases.

This phase usually compares the new treatment regimen with the standard treatment.

Clinical trials in cancer do not usually use a placebo, however, if there is no treatment currently available then using a placebo may be acceptable. Sometimes it is planned for the trial drug to be given with another standard treatment; in these circumstances the trial drug and the standard treatment could be compared to the standard treatment and a placebo.

PHASE IV

After a treatment is licensed for use in patients, a phase IV trial, is carried out to further optimise the treatment.

Health Professionals requiring information on trials and access to our professional section of the website can register here.