- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00993486
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Quebec
-
Montreal, Quebec, Canadá, H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
|
Experimental: L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Periodo de tiempo: Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Immune reconstitution
Periodo de tiempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Rate of disease relapse
Periodo de tiempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence and severity of graft-versus-host disease
Periodo de tiempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence of adverse drug reactions
Periodo de tiempo: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
|
Incidence and severity of infections
Periodo de tiempo: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Denis-Claude Roy, MD, Maisonneuve-Rosemont Hospital, Montréal, Canada
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR-GVH-001
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