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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00907582
Other study ID # MHOPES-APL09
Secondary ID
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


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
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