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Completed

NCT Number: NCT03042585

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

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.

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Key information

Conditions

Relapsed Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Refractory Non-Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patrick Stiff, MD

Maywood, Illinois, 60153, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Body Irradiation

Radiation

When radiation is given in a way to cover the whole body, it is called total body irradiation.

Primary outcomes

  1. Determine the frequency and severity of adverse events by evaluating grade 3 and grade 4 adverse events.

    Time frame: 4 weeks

    Any grade 3 or 4 dose limiting toxicities as described : • Heart failure with only minor response to medical therapy

    • Hemorrhagic cystitis with frank blood requiring sclerosing agent or other surgical procedure
    • Acute kidney failure requiring dialysis
    • Interstitial pneumonitis requiring ventilatory support or FiO2 > 50% x 24hrs
    • Bilirubin > 20 mg/dL
    • Unexplained seizures or coma
    • Severe mucositis requiring intubation for airway protection
    • Ileus requiring nasogastric decompression.
    • Death

Secondary outcomes

  1. Blood work will be used to evaluate recovery of white blood cells, red blood cells and platelets.

    Time frame: 4 weeks

    To evaluate labwork during treatment and for 28 days post treatment

  2. Pulmonary Function Test will be used to evaluate side effects of total body irradiation

    Time frame: 1 year

    Pulmonary Function Test will be used to evaluate side effects of total body irradiation.

  3. CT scan or physical exam will be used to evaluate progression free survival.

    Time frame: 1 year

    CT scan or physical exam will be used to evaluate progression free survival as deemed necessary.

  4. Mucositis measured by investigators.

    Time frame: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.

    Mucositis physical examination done by investigators by accessing the mouth using the WHO (World Health Organization) oral toxicity scale.

  5. Number of participants with Grade 4 through 5 Adverse Events that are related to study treatment, grading according to NCI CTCAE Version 3.

    Time frame: 28 days post treatment

    Dose-limiting toxicities that are probably or definitely related to the treatment regimen.

  6. Mucositis measured by oral mucositis questionnaires

    Time frame: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.

    The participants will complete the oral mucositis daily questionnaires prior to the physical assessment. The questionnaire includes the participants self-reported mouth and throat soreness.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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