Study on High Dose Chemotherapy and Stem Cell Infusion for Patients with Peripheral T-cell Lymphoma in Complete Remission

Program Overview

The study aims to compare the effects of high dose chemotherapy and a patient's own stem cells against just observation in patients with peripheral T-cell lymphoma who have fully responded to initial chemotherapy. Typically, after achieving complete remission, patients may either be observed or receive high dose chemotherapy followed by a stem cell transplant. This study will help determine if the transplant offers additional benefits. The process involves using chemotherapy to kill cancer cells and make space in the bone marrow for new stem cells to grow. These stem cells, collected before treatment, are then returned to the patient to replace the blood-forming cells destroyed by chemotherapy. The study will assess if this approach is more effective than observation alone.

Description

The main goal of this study is to see if patients who receive high dose chemotherapy and their own stem cells live longer without the cancer coming back, compared to those who are just observed. Secondary goals include comparing overall survival rates and understanding how different factors like cancer type and initial treatment affect outcomes. The study will also look at how often the cancer returns and the impact of any remaining cancer cells after treatment.

Participants will be randomly assigned to one of two groups:

• Group 1: Patients will be observed and monitored with regular blood tests, optional bone marrow tests, and scans.
• Group 2: Patients will undergo a process to collect their stem cells, receive high dose chemotherapy, and then have their stem cells infused back into their body. They will also have regular tests and scans.

After treatment, patients will have follow-up visits every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years, totaling 12 years from when they joined the study.

Eligibility Criteria

Locations