ASCT for Relapsed APL After Molecular Remission

Patrocinador principal: Shanghai Jiao Tong University School of Medicine

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).

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.

• Acute Promyelocytic Leukemia
• Relapse

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

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

China

November 2014

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

• PCR negative

• Leukemia
• Leukemia, Promyelocytic, Acute
• Recurrence

Etiqueta: ASCT in relapsed APL

Tipo: Experimental

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

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)