ASCT for Relapsed APL After Molecular Remission

Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning

Patrocinadores

Patrocinador principal: Shanghai Jiao Tong University School of Medicine

Fuente Shanghai Jiao Tong University School of Medicine
Resumen breve

For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of mylotarg. Autologous hematopoietic cell transplantation using a polymerase chain reaction (PCR) negative graft is important treatment option to obtain sustainable remission. This study is to test the efficacy and the safety of conditioning regimen with idarubicin and busulfan for relapsed Acute Promyelocytic Leukemia (APL).

Descripción detallada

Once relapsed acute promyelocytic leukemia achieved molecular remission after all-trans retinoic acid (ATRA) and arsenic treatment, PBSC was mobilized and collected with further confirmation of molecular remission via RT-PCR.

Patients received autologous hematopoietic cell transplantation.

Estado general Terminated
Fecha de inicio June 2009
Fecha de Terminación May 2014
Fecha de finalización primaria May 2014
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
disease free survival 3 years
Resultado secundario
Medida Periodo de tiempo
overall survival 3 years
transplantation related mortality 3 years
Inscripción 5
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: autologous hematopoietic cell transplantation

Descripción: Autologous hematopoietic cell transplantation and condition with the following: idarubicin 15mg/m2•d day -11 and -10; busulfan 0.8mg/kg•q6h day -6 to -3.

Etiqueta de grupo de brazo: ASCT in relapsed APL

Elegibilidad

Criterios:

Inclusion Criteria:

- Men or women between age 18-60 years old

- Acute promyelocytic leukemia after relapse with confirmed cytogenetics t(15;17) and molecular analysis (PML-RARalpha)

- Mobilized peripheral CD34+ over 2x106/kg with negative PML-RAR alpha confirmed by PCR

- European Cooperative Oncology Group performance status 0-3

- Serum bilirubin < 1.5x the upper limit of normal (ULN)

- Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN

- Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

- Woman of child bearing potential

- Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy

- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)

- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure

- Known allergy to idarubicin

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
JIong HU, M.D. Principal Investigator Shanghai Rui Jin Hospital
Ubicación
Instalaciones: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Ubicacion Paises

China

Fecha de verificación

November 2014

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Shanghai Jiao Tong University School of Medicine

Nombre completo del investigador: Jiong HU

Título del investigador: Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: ASCT in relapsed APL

Tipo: Experimental

Descripción: autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov