Now Enrolling: The PTCL-STAT research study is testing the use of stem cell transplants for patients with an aggressive type of lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare and fast-growing form of non-Hodgkin lymphoma. It develops from white blood cells called T-cells and/or natural killer cells, and can affect the tissues of the lymph nodes, spleen, gastrointestinal tract, or skin. After initial treatment with chemotherapy drugs (and radiation in very specific cases), many patients go into remission. This means all signs and symptoms of cancer have disappeared. Unfortunately, the cancer often returns (or recurs). The percentage of patients alive at five years after treatment is only about 30-40 percent.

Since PTCL often recurs, doctors sometimes recommend further treatment—even while the patient is in remission. One approach is an autologous stem cell transplant (ASCT). ASCT is a procedure in which:

1. Stem cells are collected from the patient
2. The patient undergoes high doses of chemotherapy
3. The patient’s stem cells are then returned to their body

The purpose of ASCT is to restore the body's ability to make normal blood cells. Such intensive treatments usually destroy cancer cells better than standard treatments—but the process is physically demanding. The key is to keep patients in remission and prevent relapses. However, researchers do not know whether ASCT helps patients with PTCL because this has never been studied in a randomized controlled trial.

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is now offering the EA4232/PTCL-STAT clinical trial to do just that. It is the first randomized phase 3 trial to compare survival with and without ASCT in patients with PTCL who are in remission.

To be eligible for the study, patients must have already received treatment with chemotherapy. Imaging tests must show that they are in complete remission. After enrolling, patients will be randomly assigned by a computer to one of two groups. The first group will have the usual follow-up visits and scans with their doctor, but no further treatment (also known as observation). The second group will receive the ASCT procedure (described above). All patients will be followed by their doctor for up to 12 years.

Additional treatment with stem cell transplantation (ASCT), which includes high-dose chemotherapy, involves significant risks and side effects. If this trial finds that this approach does not improve the current survival rate, then future patients will be spared these difficulties. If the approach is effective, both patients and physicians can rest assured the additional treatment is the right choice for them.

Learn more about EA4232/PTCL-STAT at ecog-acrin.org.