- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Illinois
-
Maywood, Illinois, États-Unis, 60153
- Patrick Stiff, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: 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.
|
Expérimental: 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.
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Determine the frequency and severity of adverse events by evaluating grade 3 and grade 4 adverse events.
Délai: 4 weeks
|
Any grade 3 or 4 dose limiting toxicities as described : • Heart failure with only minor response to medical therapy
|
4 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Blood work will be used to evaluate recovery of white blood cells, red blood cells and platelets.
Délai: 4 weeks
|
To evaluate labwork during treatment and for 28 days post treatment
|
4 weeks
|
Pulmonary Function Test will be used to evaluate side effects of total body irradiation
Délai: 1 year
|
Pulmonary Function Test will be used to evaluate side effects of total body irradiation.
|
1 year
|
CT scan or physical exam will be used to evaluate progression free survival.
Délai: 1 year
|
CT scan or physical exam will be used to evaluate progression free survival as deemed necessary.
|
1 year
|
Mucositis measured by investigators.
Délai: 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.
|
At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
|
Number of participants with Grade 4 through 5 Adverse Events that are related to study treatment, grading according to NCI CTCAE Version 3.
Délai: 28 days post treatment
|
Dose-limiting toxicities that are probably or definitely related to the treatment regimen.
|
28 days post treatment
|
Mucositis measured by oral mucositis questionnaires
Délai: 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.
|
At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Patrick Stiff, MD, Loyola University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 108993
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Lymphome non hodgkinien réfractaire
-
Shandong Provincial HospitalInconnueApplication clinique de la doxorubicine (PLD) liposome polyéthylène glycol dans le lymphome primaireLymphome non hodgkinien ; maladie de HodgkinChine
-
University Hospital, BrestComplétéImagerie diagnostique | Lymphome non hodgkinien récidivant | Maladie de Hodgkin en rechute, adulte | Lymphome malin
-
Baylor College of MedicineNational Cancer Institute (NCI); The Methodist Hospital Research Institute; Center...Actif, ne recrute pasMaladie de Hodgkin | Lymphome de Hodgkin | Lymphome non hodgkinienÉtats-Unis
-
TakedaComplétéLymphome de Hodgkin CD30-positif non traitéJapon
-
CytokineticsComplétéLymphome non hodgkinien | La maladie de HodgkinÉtats-Unis, Fédération Russe
-
Tomsk National Research Medical Center of the Russian...Uppsala UniversityComplétéLymphome hodgkinien, adulte | Lymphome non hodgkinien, adulteFédération Russe
-
TakedaComplétéMaladie de Hodgkin | Lymphome anaplasique à grandes cellulesChine
-
AstraZenecaRecrutementLymphome | Lymphome de Hodgkin | Non hodgkinienCorée, République de, Royaume-Uni, Italie, Allemagne, France, Espagne, États-Unis, Australie
-
Masonic Cancer Center, University of MinnesotaRecrutementLymphome de Hodgkin | Lymphome non hodgkinienÉtats-Unis
-
The Hospital for Sick ChildrenComplétéLymphome de Hodgkin | Lymphome non hodgkinienCanada
Essais cliniques sur Total body irradiation
-
University of California, DavisColorado SPORE Developmental Research ProgramActif, ne recrute pas
-
Linnaeus UniversityHalmstad UniversityComplétéDouleur au cou, postérieureSuède
-
M.D. Anderson Cancer CenterElekta LimitedSuspendu
-
Assistance Publique - Hôpitaux de ParisHotel Dieu Hospital; Withings; Hôpital Lariboisière Fernand WidalPas encore de recrutement
-
University of South CarolinaActif, ne recrute pasFrénésie alimentaire | L'image corporelle | Comportement alimentaire | Nutrition, Santé | Alimentation désordonnéeÉtats-Unis
-
Assistance Publique - Hôpitaux de ParisWithingsPas encore de recrutementLymphome non hodgkinien | Myélome multiple
-
Florida State UniversityComplétéTrouble de l'alimentationÉtats-Unis
-
University Hospital, MontpellierComplétéPerte de poidsFrance
-
University of MiamiHyperVibe Pty LtdRetiréComposition corporelle, Bénéfique | Forme physiqueÉtats-Unis
-
University Hospital, MontpellierComplétéPerte de poidsFrance