ASCT for Relapsed APL After Molecular Remission

Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00907582
• Other study ID #: MHOPES-APL09
• Status: Terminated
• Phase: Phase 2
• First received: May 21, 2009
• Last updated: December 1, 2014
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia, Promyelocytic, Acute
• Relapse

Intervention

Procedure:
• autologous hematopoietic cell transplantation
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.

Locations

Country	Name	City	State
China	Rui Jin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		3 years	No
Secondary	overall survival		3 years	Yes
Secondary	transplantation related mortality		3 years	Yes