Historical Data Analysis of Complete Remission in Childre... | NCT02303522

Studies
Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

NCT02303522

Sponsor

Amgen

Status

Completed

Last Update Posted

May 6, 2020Actual

Enrollment

207Estimated

Phase

Not provided

Conditions

B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Interventions

Other: not applicable - observational study

Countries

Austria
Germany
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

May 2020

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

Dec 9, 2014Actual

Primary Completion Date

Jan 22, 2015Actual

Completion Date

Jan 22, 2015Actual

First Submitted Date

Nov 6, 2014

First Submission Date that Met QC Criteria

Nov 28, 2014

First Posted Date

Dec 1, 2014Estimated

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

May 4, 2020

Last Update Posted Date

May 6, 2020Actual

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

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Detailed Description

A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

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

207Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects		All subjects will be included in a unique cohort	Other: Other: not applicable - observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Other: not applicable - observational study	Other	No intervention exists as this is a retrospective observational study	All subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hematological Complete Remission (CR)	To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)	Approx. 1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	OS following salvage therapy: defined as time to death.	Approx. 1 year
Molecular CR	Defined as MRD <10-4 measured either by PCR or flow cytometry.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
2nd or later relapse after chemotherapy (with no prior transplantation),
Relapse after HSCT, or
Refractory disease
Had treatment for relapsed or refractory disease between 2005-2012
Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion criteria:

No CNS involvement at relapse
No previous treatment with blinatumomab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Vienna		1090	Austria
Research Site

Label	URL
AmgenTrials clinical trials website	View source

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided