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O estudo 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 ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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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 Randomizado Sobrevida global

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O estudo clínico NCT07493408 (ASIM-POST Ph+) vai avaliar tratamento 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. Este é um estudo intervencionista de Fase II. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 30 de março de 2026, com o objetivo de incluir 45 participantes. Coordenado por a Universidade de Hong Kong e deve ser concluído em 31 de dezembro de 2037. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
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).

The main questions it a...

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Descrição detalhada
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 mais
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)

Condições 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
Outros IDs do estudo
  • ASIM-POST Ph+
  • ASCPT-01
Número NCT
NCT07493408
Data de início (real)
2026-03-30
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2037-12-31
Inscrição (estimada)
45
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ainda não recrutando
Palavras-chave
Ph+ B-ALL
CML-BP
Asciminib
Asciminib add-on
allogeneic HSCT maintenance
Asciminib with Imatinib
Asciminib with Nilotinib
Asciminib with Dasatinib
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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
OutroControl 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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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.
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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.
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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 logoUniversidade de Hong Kong335 estudos clínicos ativos para explorar
Responsável pelo estudo
Professor Yok-lam Kwong, Investigador principal, Professor, The University of Hong Kong
Contato central do estudo
Contato: Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
Contato: Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
1 Locais do estudo em 1 países
The University of Hong Kong, Hong Kong, Hong Kong
Rebecca W.M. CHUNG, Contato, +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