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ASCT for Relapsed APL After Molecular Remission

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT00907582
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
59
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2009
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. disease free survival [3 years]

Secondary Outcome Measures

  1. overall survival [3 years]

  2. transplantation related mortality [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00907582
Other Study ID Numbers:
  • MHOPES-APL09
First Posted:
May 22, 2009
Last Update Posted:
Dec 2, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
PCR negative
Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Recurrence

Study Results

No Results Posted as of Dec 2, 2014