- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03042585
Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Illinois
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Maywood, Illinois, Spojené státy, 60153
- Patrick Stiff, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Dose Level 1
The participants will receive Palifermin on Day -10, -9 and -8.
Total Body Irradiation 1.64 Gy per Fraction for a total of 8 Fractions.
The total amount would be 13.12
Gy.
The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4).
Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2).
The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Participants will receive Palifermin on Day 0, +1 and +2.
|
When radiation is given in a way to cover the whole body, it is called total body irradiation.
|
Experimentální: Dose Level 2
The participants will receive Palifermin on Day -10, -9 and -8.
Total Body Irradiation 1.76 Gy per Fraction for a total of 8 Fractions.
The total amount would be 14.08 Gy.
The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4).
Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2).
The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Participants will receive Palifermin on Day 0, +1 and +2.
|
When radiation is given in a way to cover the whole body, it is called total body irradiation.
|
Experimentální: Dose Level 3
The participants will receive Palifermin on Day -10, -9 and -8.
Total Body Irradiation 1.88 Gy per Fraction for a total of 8 Fractions.
The total amount would be 15.04 Gy.
The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4).
Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2).
The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Participants will receive Palifermin on Day 0, +1 and +2.
|
When radiation is given in a way to cover the whole body, it is called total body irradiation.
|
Experimentální: Dose Level 4
The participants will receive Palifermin on Day -10, -9 and -8.
Total Body Irradiation 2.00 Gy per Fraction for a total of 8 Fractions.
The total amount would be 16 Gy.
The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4).
Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2).
The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Participants will receive Palifermin on Day 0, +1 and +2.
|
When radiation is given in a way to cover the whole body, it is called total body irradiation.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Determine the frequency and severity of adverse events by evaluating grade 3 and grade 4 adverse events.
Časové okno: 4 weeks
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Any grade 3 or 4 dose limiting toxicities as described : • Heart failure with only minor response to medical therapy
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4 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Blood work will be used to evaluate recovery of white blood cells, red blood cells and platelets.
Časové okno: 4 weeks
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To evaluate labwork during treatment and for 28 days post treatment
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4 weeks
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Pulmonary Function Test will be used to evaluate side effects of total body irradiation
Časové okno: 1 year
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Pulmonary Function Test will be used to evaluate side effects of total body irradiation.
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1 year
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CT scan or physical exam will be used to evaluate progression free survival.
Časové okno: 1 year
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CT scan or physical exam will be used to evaluate progression free survival as deemed necessary.
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1 year
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Mucositis measured by investigators.
Časové okno: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
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Mucositis physical examination done by investigators by accessing the mouth using the WHO (World Health Organization) oral toxicity scale.
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At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
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Number of participants with Grade 4 through 5 Adverse Events that are related to study treatment, grading according to NCI CTCAE Version 3.
Časové okno: 28 days post treatment
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Dose-limiting toxicities that are probably or definitely related to the treatment regimen.
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28 days post treatment
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Mucositis measured by oral mucositis questionnaires
Časové okno: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
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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.
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At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Patrick Stiff, MD, Loyola University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 108993
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