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ASCT for Relapsed APL After Molecular Remission

NCT ID: NCT00907582

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Acute Promyelocytic Leukemia Relapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASCT in relapsed APL

autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission

Group Type EXPERIMENTAL

autologous hematopoietic cell transplantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIong HU, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Rui Jin Hospital

Locations

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Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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MHOPES-APL09

Identifier Type: -

Identifier Source: org_study_id