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ASCT for Relapsed APL After Molecular Remission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907582
Recruitment Status : Terminated (slow recruitment)
First Posted : May 22, 2009
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Relapse Procedure: autologous hematopoietic cell transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
Study Start Date : June 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: ASCT in relapsed APL
autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
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.

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
  2. transplantation related mortality [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907582

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Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Principal Investigator: JIong HU, M.D. Shanghai Rui Jin Hospital
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Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine Identifier: NCT00907582    
Other Study ID Numbers: MHOPES-APL09
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
PCR negative
Additional relevant MeSH terms:
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Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Leukemia, Myeloid, Acute
Leukemia, Myeloid