Autologous Peripheral Blood Stem Cell Transplantation Wit... | NCT00531583

Studies
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor

NCT00531583

Sponsor

King Faisal Specialist Hospital & Research Center

Status

Completed

Last Update Posted

Jan 5, 2016Estimated

Enrollment

350Actual

Phase

Not Applicable

Conditions

Leukemia, Monocytic, Acute

Interventions

Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation

Countries

Saudi Arabia

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

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Sep 17, 2007

First Submission Date that Met QC Criteria

Sep 18, 2007

First Posted Date

Sep 19, 2007Estimated

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

Jan 4, 2016

Last Update Posted Date

Jan 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st & 2nd complete remission w/no HLA matched related donor

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation	Drug	Autologous PBSCT

Measure	Description	Time Frame
Efficacy		2009-2015

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with AML in 1st & 2nd complete remission w/no HLA matched related donor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fahad AlMohareb	KFSH&RC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KFSH&RC		Riyadh		1211	Saudi Arabia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases