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ASCT for Relapsed APL After Molecular Remission

This study has been terminated.
(slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907582
First Posted: May 22, 2009
Last Update Posted: December 2, 2014
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.
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
  Purpose
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 Intervention Phase
Acute Promyelocytic Leukemia Relapse Procedure: autologous hematopoietic cell transplantation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:

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

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ]
  • transplantation related mortality [ Time Frame: 3 years ]

Enrollment: 5
Study Start Date: June 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00907582


Locations
China
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: JIong HU, M.D. Shanghai Rui Jin Hospital
  More Information

Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00907582     History of Changes
Other Study ID Numbers: MHOPES-APL09
First Submitted: May 21, 2009
First Posted: May 22, 2009
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:
Leukemia
Recurrence
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Idarubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action