Study of Prognostic Factors in Adult Lymphoblastic Lymphoma | NCT03571997

Studies
Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

NCT03571997

Sponsor

PETHEMA Foundation

Status

Unknown status

Last Update Posted

Feb 1, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Lymphoblastic Lymphoma

Interventions

Not provided

Countries

Spain

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

Jan 2022

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

Jun 15, 2018Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Jun 18, 2018

First Submission Date that Met QC Criteria

Jun 18, 2018

First Posted Date

Jun 28, 2018Actual

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 31, 2022

Last Update Posted Date

Feb 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central [CNS], bone marrow [MO], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present

Detailed Description

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description pronostic factors	Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL	1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival	To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols	1 year
Progression free survival	To study if there has been an increase in progression-free survival (PFS) in patients diagnosed with ALL in the different PETHEMA protocols

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients> 15 years diagnosed with ALL and treated with the PETHEMA protocols for ALL

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel Sagüés Serrano, Dr	Contact	972 225 158		msagues@iconcologia.net
Josep Mª Ribera, Dr	Contact	93 4978987 (ext. 3939)		jribera@iconcologia.net\|

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Mútua de Terrassa	Recruiting	Terrassa	Barcelona		Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided