Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL

Completed · Not applicable

Conditions studied: Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma

In brief

Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an autologous transplant are likely to suffer a relapse because standard myeloablative preparative regimens are unable to produce a cure. The majority of these participants do not have a stem cell donor available, are too frail to undergo an allogeneic transplant, or refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma have had a very poor outcome. To take advantage of the low transplant related mortality associated with an autologous transplantation, the investigators propose modifying the preparative regimen to make it more effective without increasing toxicity. By increasing the dose of radiation while administering the protective growth factor palifermin (Kepivance), the investigators hope to decrease the risk of relapse without increasing transplant related mortality. Three prospective randomized trials have studied different radiation schemes as a part of the TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML or CML. As a group these trials showed that higher doses of TBI in these older studies decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective studies have also postulated that higher dose radiation led to less risk of relapse.

Key facts

Study ID

NCT03042585

Run by

Loyola University

People needed

17

Starts

2006-06-01

Expected to finish

2018-12-01

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years of age or older
• Participants scheduled to undergo autologous stem cell transplantation with relapsed or refractory non-Hodgkin's Lymphoma with less than a partial remission to salvage therapy.
• Participants scheduled to undergo autologous stem cell transplantation with relapsed or refractory non-Hodgkin's Lymphoma with any site of disease 2 cm or greater on pre-transplant imaging.
• Participants must have a performance status (PS) of 0-1.
• Participants must have acceptable kidney function.
• Acceptable pulmonary function test of the lungs.
• Acceptable liver function tests.

You may not qualify if…

• Participants must not have cutaneous T-cell, mantle cell, or lymphoblastic lymphoma.
• Participants must not have prior peripheral blood or marrow transplantation.
• Participants must not have prior radiation.
• Participants must not have significant history of uncontrolled cardiac disease; for example, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• Participants must not have active bacterial, fungal, or viral infection.

Where it is running

• Patrick Stiff, MD — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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