ASCT for Relapsed APL After Molecular Remission

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907582

Enrollment

Registered

2009-05-22

Start date

2009-06-30

Completion date

2014-05-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Promyelocytic Leukemia, Relapse

Keywords

PCR negative

Brief 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).

Detailed 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.

Interventions

PROCEDUREautologous 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
disease free survival	3 years

Secondary

Measure	Time frame
overall survival	3 years
transplantation related mortality	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026