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El ensayo clínico NCT07493408 (ASIM-POST Ph+) para Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia, Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL), Haematopoietic Stem Cell Transplant, Allogeneic está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML (ASIM-POST Ph+) Fase II 45 First-in-Class Aleatorizado Supervivencia global

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El ensayo clínico NCT07493408 (ASIM-POST Ph+) está diseñado para estudiar el tratamiento de Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia, Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL), Haematopoietic Stem Cell Transplant, Allogeneic. Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 30 de marzo de 2026 hasta completar 45 participantes. Dirigido por la Universidad de Hong Kong, se espera que finalice el 31 de diciembre de 2037. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).

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Descripción detallada
Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (myeloid or lymphoid) (CML-BP) represent a group of high-risk disease. The outcome has improved since the introduction of tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients still relapse despite undergoing allogeneic (allo-) hematopoietic stem cell transplant (...Mostrar más
Título oficial

Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)

Condiciones médicas
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Blastic Transformation of Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)Haematopoietic Stem Cell Transplant, Allogeneic
Otros ID del estudio
  • ASIM-POST Ph+
  • ASCPT-01
Número del NCT
NCT07493408
Inicio del estudio (real)
2026-03-30
Última actualización
2026-03-25
Fecha de finalización (estimada)
2037-12-31
Inscripción (prevista)
45
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Palabras clave
Ph+ B-ALL
CML-BP
Asciminib
Asciminib add-on
allogeneic HSCT maintenance
Asciminib with Imatinib
Asciminib with Nilotinib
Asciminib with Dasatinib
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalStudy Arm (ASC + TKIs)
Asciminib (ASC) add-on with a 2 years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib. TKI will be added from 5th week onwards after.
Asciminib add-on
Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)
Imatinib
Imatinib 300mg QD (Ramp-up from 100mg QD for first 4-weeks, 200mg QD for following 4-weeks then 300mg QD for subsequent weeks), Maximum 2-years treatment
Dasatinib
Dasatinib 50mg QD (Ramp-up from 20mg QD for first 4-weeks, 40mg QD for following 4-weeks then 50mg QD for subsequent weeks), Maximum 2-years treatment
Nilotinib
Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment
OtrosControl Arm (TKIs only)
2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib
Imatinib
Imatinib 300mg QD (Ramp-up from 100mg QD for first 4-weeks, 200mg QD for following 4-weeks then 300mg QD for subsequent weeks), Maximum 2-years treatment
Dasatinib
Dasatinib 50mg QD (Ramp-up from 20mg QD for first 4-weeks, 40mg QD for following 4-weeks then 50mg QD for subsequent weeks), Maximum 2-years treatment
Nilotinib
Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Morphological relapse-free survival (M-RFS)
Morphological relapse-free survival (M-RFS) is defined as the time from date of allogeneic Hematopoietic Stem Cell Transplantation (HSCT) until the date of first documented morphological relapse or death from any cause, whichever occurs earlier. Morphological relapse is defined as the presence of ≥ 5% blasts in the bone marrow and/or evidence of new onset extramedullary disease.
From date of allogeneic HSCT until the date of first documented morphological relapse or death from any cause, whichever occurs earlier, up to 12 years.
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Molecular relapse-free survival (m-RFS)
Molecular RFS is defined as the time from the date of randomization to the date of documented molecular relapse or the date of death from any causes, whichever occurs earlier. Molecular relapse was defined as loss of major molecular response (MMR, defined as BCR::ABL1 transcript ≤0.1% on the international scale for p210 transcript and/or a 3-log reduction from baseline for p190 transcript).
From date of randomization until the date of first documented molecular relapse or death from any cause, whichever occurs earlier, up to 12 years.
Cumulative incidence of grade II-IV acute Graft versus Host Disease (acute GvHD)
Cumulative incidence of grade II-IV acute GvHD (by Mount Sinai Acute GvHD International Consortium \[MAGIC\] criteria)
Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Cumulative incidence of chronic Graft versus Host Disease (chronic GvHD)
Cumulative incidence of moderate to severe chronic GvHD (by National Institute of Health \[NIH\] criteria) requiring systemic treatment
From enrollment through study completion, an average of 2 years
Treatment toxicities and Adverse Events (AEs)
Number of incidence of Treatment toxicities and adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 throughout the study duration, from baseline through 24 months post-treatment or end of study participation.
From randomization through treatment completion, an average of 2 years
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from the date of Hematopoietic Stem Cell Transplantation (HSCT) to the date of morphological disease relapse, molecular relapse, onset of acute or chronic GvHD, or death from any cause.
From date of allogeneic HSCT until the date of first documented morphological relapse, molecular relapse, onset of acute of chronic GvHD or death from any cause, whichever occurs earlier, up to 12 years.
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of Hematopoietic Stem Cell Transplantation (HSCT) to the time of death.
From date of allogeneic HSCT until the date of death from any cause or trial completion, whichever occurs earlier, up to 12 years.
2-year morphological relapse-free survival rate (2-year M-RFS rate)
The proportion of subjects with morphological relapse-free survival at 2 years from time of Hematopoietic Stem Cell Transplantation (HSCT).
From date of allogeneic HSCT until the date of first documented morphological relapse, molecular relapse, or death from any cause, whichever occurs earlier, up to 2 years.
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an informed consent form (ICF) indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
  2. Age ≥ 18 years
  3. Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT
  4. Patients must have received TKI therapy in induction/consolidation therapy
  5. Absolute neutrophil count ≥ 1.0 × 109/L
  6. Platelet count ≥ 50 × 109/L

  1. Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
  3. Uncontrolled hypertension
  4. Corrected QT interval (QTc) > 460 milliseconds for women or > 450 milliseconds for men
  5. Amylase and lipase values > 3 × upper limit of normal
  6. Patients refused standard TKI maintenance post-HSCT
  7. Unable to comply with study requirements
  8. Patients taking ponatinib as choice of TKI
  9. Patients with documented T315I mutation
The University of Hong Kong logoUniversidad de Hong Kong335 estudios activos para explorar
Parte responsable del estudio
Professor Yok-lam Kwong, Investigador principal, Professor, The University of Hong Kong
Contactos centrales del estudio
Contacto: Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
Contacto: Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
1 Centros del estudio en 1 países
The University of Hong Kong, Hong Kong, Hong Kong
Rebecca W.M. CHUNG, Contacto, +852 2255 4155, [email protected]
Yok-Lam Kwong, MBBS, MD, FRCP(UK), FRCPath(UK, Investigador principal
Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK), Subinvestigador
Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK), Subinvestigador