Conventional and Experimental Chemotherapy With Allogenei... | NCT01785953

Studies
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia

NCT01785953

Sponsor

Azienda Ospedaliera San Giovanni Battista

Status

Unknown status

Last Update Posted

Feb 7, 2013Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Acute Myeloid Leukemia

Interventions

Not provided

Countries

Italy

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

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 7, 2013Estimated

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

Feb 6, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benedetto Bruno, MD, Azienda Ospedaliera San Giovanni BattistaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera San Giovanni BattistaOTHER

Collaborators

Not provided

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

The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
1

Measure	Description	Time Frame
Overall survival		1 year
Event-free survival		1 year

Eligibility Module

Eligibility Criteria

Patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Acute myeloid leukemia patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benedetto Bruno, MD	Contact	+390116336728		benedetto.bruno@unito.it
Benedetto Bruno, MD	Contact	+390116336728		gismm2001@yahoo.com

Overall Officials

Name	Affiliation	Role
Benedetto Bruno, MD	Divisione di Ematologia-Città della Salute e della Scienza di Torino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Città della Salute e della Scienza di Torino	Recruiting	Torino		10126	Italy

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided