ASCT for Relapsed APL After Molecular Remission | NCT00907582

Studies
ASCT for Relapsed APL After Molecular Remission

NCT00907582

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Terminated

Last Update Posted

Dec 2, 2014Estimated

Enrollment

5Actual

Phase

Phase 2

Conditions

Acute Promyelocytic Leukemia
Relapse

Interventions

autologous hematopoietic cell transplantation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow recruitment

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

May 21, 2009

First Submission Date that Met QC Criteria

May 21, 2009

First Posted Date

May 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASCT in relapsed APL	Experimental	autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission	Procedure: autologous hematopoietic cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous hematopoietic cell transplantation	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.

Measure	Description	Time Frame
disease free survival		3 years

Measure	Description	Time Frame
overall survival		3 years
transplantation related mortality		3 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine		Shanghai		200025	China

Condition Browse Module

MeSH Terms

ID	Term
D015473	Leukemia, Promyelocytic, Acute
D012008	Recurrence

Ancestor Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

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