- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07607327
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD) (FORWARD)
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD): A Multicenter, Prospective Observational Cohort Study in US Transplant Centers
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nishant Dwivedi, MD, PhD
- Número de teléfono: 508-981-6087
- Correo electrónico: ndwivedi@caredx.com
Ubicaciones de estudio
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California
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Brisbane, California, Estados Unidos, 94080
- CareDx, Inc.
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Contacto:
- Nishant Dwivedi, MD, PhD
- Número de teléfono: 508-981-6087
- Correo electrónico: ndwivedi@caredx.com
-
Contacto:
- Nishant Dwivedi, MD, PhD
- Correo electrónico: ndwivedi@caredx.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged 18 years or above.
- The participant must have one of the following diseases: AML or MDS (including CMML) and be eligible for allogeneic hematopoietic stem cell transplant. For participants with active disease (> 5% blasts) before HCT, the treating physician must have the intent to perform a bone marrow examination at day 30 post-HCT as SOC patient management to confirm complete remission (<5% blasts).
- Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor.
- Participant can be enrolled before, at, or up to 1-month post-allo-HCT as long as the participant is in complete remission (CR) at Day 30 and that a recipient pre-transplant or donor sample is available for baseline genotyping (reference). If the reference sample is unavailable or fails testing, the buccal swab collected at Day 30 may be used as the reference sample.
- Myeloablative or reduced intensity/non-myeloablative conditioning except T-cell depleting therapies (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab).
- Any graft versus host disease (GVHD) prophylaxis regimen.
- Willing and able to provide written informed consent.
- Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments
Exclusion Criteria:
- History of prior allo-HCT or any prior solid organ transplant.
- Syngeneic donor (identical twin).
- T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of antithymocyte globulin or alemtuzumab in the conditioning regimen)
- Cord blood graft.
- Pregnancy
- Any condition that, in the investigator's opinion, would interfere with the participant's ability to comply with study procedures or jeopardize their safety.
- Concurrent participation in an interventional or maintenance clinical trial for post allo-HCT relapse prevention; co-enrollment with other trials, such as those intended for GVHD / infection prevention or improving supportive care, is allowed.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To evaluate AlloHeme test performance in predicting post-transplant relapse (by FDA criteria) or any cytogenetic/molecular evidence of disease resulting in unplanned treatment intervention in AML and MDS patients.
Periodo de tiempo: 12 months
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The performance of AlloHeme test in predicting post-transplant relapse (by FDA criteria) or any cytogenetic/molecular evidence of disease resulting in unplanned treatment intervention (modified FDA criteria) in patients with AML and MDS will be evaluated using:
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The performance of the AlloHeme test in predicting post-transplant relapse as defined by the FDA in patients with AML and MDS will be evaluated using: o Sensitivity o Specificity o PPV o NPV o AuROC
Periodo de tiempo: 12 months
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12 months
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The median lead time from a positive AlloHeme test result to a relapse in post-allo-HCT AML and MDS patients.
Periodo de tiempo: 12 months
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Lead time will be defined as the duration (in days) between the date of the first AlloHeme posi-tive result and the date of documented relapse.
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12 months
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Hazard Ratio for relapse outcome.
Periodo de tiempo: 12 months
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12 months
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The AlloHeme test performance in predicting post-transplant relapse will be compared with bone marrow MFC MRD and molecular MRD methods (NGS, qPCR, ddPCR)* in patients with AML and MDS using sensitivity, specificity, PPV, NPV, and AuROC measures.
Periodo de tiempo: 12 months
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*If either test yields a positive result, the overall assessment will be considered positive. For molecular MRD, a "positive" result must correspond to a known pathogenic variant judged by the treating physi-cian to be clinically relevant for relapse. MFC and/or molecular MRD performance will be based on transplant center-provided bone mar-row testing results. |
12 months
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The performance of the AlloHeme and peripheral blood-based STR-PCR tests in predicting post-transplant relapse in patients with AML and MDS will be evaluated using the following measures: o Sensitivity o Specificity o PPV o NPV o AuROC
Periodo de tiempo: 12 months
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12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The performance of the AlloHeme test in predicting post-transplant relapse will be described in subgroups of interest (AML vs MDS/CMML, conditioning regimen, risk assessment, etc.)
Periodo de tiempo: 12 months
|
Performance will be evaluated using:
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12 months
|
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The performance of the AlloHeme test in predicting or detecting positive MRD as measured on bone marrow MFC MRD and/or molecular MRD testing modalities.
Periodo de tiempo: 12 months
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Performance will be evaluated using:
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12 months
|
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Relapse-free survival will be measured as the time interval from allo-HCT to the documented date of relapse or death from any cause and will be compared between the AlloHeme Positive and Negative groups.
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Procesos Patológicos
- Neoplasias
- Atributos de la enfermedad
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Leucemia Mieloide
- Enfermedades de la médula ósea
- Anemia
- Leucemia
- Síndromes mielodisplásicos
- Anemia Refractaria
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Reaparición
- Leucemia Mieloide Aguda
- Anemia Refractaria Con Exceso De Blastos
Otros números de identificación del estudio
- CDNACT2501
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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