ASCT for Relapsed APL After Molecular Remission

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Brief Title

ASCT for Relapsed APL After Molecular Remission

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

disease free survival

Secondary Outcome

 overall survival

Condition

Acute Promyelocytic Leukemia

Intervention

autologous hematopoietic cell transplantation

Study Arms / Comparison Groups

 ASCT in relapsed APL
Description:  autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

5

Start Date

June 2009

Completion Date

May 2014

Primary Completion Date

May 2014

Eligibility 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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

JIong HU, M.D., , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT00907582

Organization ID

MHOPES-APL09


Responsible Party

Principal Investigator

Study Sponsor

Shanghai Jiao Tong University School of Medicine


Study Sponsor

JIong HU, M.D., Principal Investigator, Shanghai Rui Jin Hospital


Verification Date

November 2014