Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/4/2018 |
| Start Date: | June 2006 |
| End Date: | December 2019 |
| Contact: | Patrick Stiff, MD |
| Email: | pstiff@lumc.edu |
| Phone: | 708-327-3148 |
Phase I Study of Autologous Transplant Conditioned by Dose-Escalated Total Body Irradiation (TBI) and Standard Doses of Cyclophosphamide and Palifermin (Kepivance) for High Risk Non-Hodgkins Lymphoma
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.
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.
This is a non-randomized, open-label phase I trial in participants with non-Hodgkin's
lymphoma. The preparative regimen will be as follows:
Day -10 (prior to transplant) Palifermin treatment to prevent mouth sores Day -9 Palifermin
treatment to prevent mouth sores Day -8 Palifermin treatment to prevent mouth sores Day -7
Total Body Irradiation twice a day Day -6 Total Body Irradiation twice a day Day -5 Total
Body Irradiation twice a day Day -4 Total Body Irradiation twice a day Day -3 Cytoxan
chemotherapy infusion Day -2 Cytoxan chemotherapy infusion Day -1 Day of rest Day 0 Stem cell
infusion (bone marrow transplant), Palifermin treatment to prevent mouth sores and G-CSF
given daily until stem cells take hold (engraftment) occurs.
Day +1 Palifermin treatment to prevent mouth sores Day +2 Palifermin treatment to prevent
mouth sores
lymphoma. The preparative regimen will be as follows:
Day -10 (prior to transplant) Palifermin treatment to prevent mouth sores Day -9 Palifermin
treatment to prevent mouth sores Day -8 Palifermin treatment to prevent mouth sores Day -7
Total Body Irradiation twice a day Day -6 Total Body Irradiation twice a day Day -5 Total
Body Irradiation twice a day Day -4 Total Body Irradiation twice a day Day -3 Cytoxan
chemotherapy infusion Day -2 Cytoxan chemotherapy infusion Day -1 Day of rest Day 0 Stem cell
infusion (bone marrow transplant), Palifermin treatment to prevent mouth sores and G-CSF
given daily until stem cells take hold (engraftment) occurs.
Day +1 Palifermin treatment to prevent mouth sores Day +2 Palifermin treatment to prevent
mouth sores
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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