Efficacy of Intermediate and High Intensity Regimens in P... | NCT04699162

Studies
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia

NCT04699162

Sponsor

Christian Omar Ramos-Peñafiel, MD, PhD

Status

Completed

Last Update Posted

Jan 14, 2021Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia

Interventions

Not provided

Countries

Mexico

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 2021

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

Jul 1, 2016Actual

Primary Completion Date

Oct 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jan 5, 2021

First Submission Date that Met QC Criteria

Jan 5, 2021

First Posted Date

Jan 7, 2021Actual

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 12, 2021

Last Update Posted Date

Jan 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Omar Ramos-Peñafiel, MD, PhD, Head of the hematology hospitalization area, Hospital General de MexicoSponsor-Investigator

Lead Sponsor

Christian Omar Ramos-Peñafiel, MD, PhDOTHER_GOV

Collaborators

Not provided

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

The aim of this study is to describe the survival and relapses of patients with diagnosis of acute lymphoblastic leukemia at two tertiary level hospitals in the metropolitan area of the valley of Mexico

Detailed Description

Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from July, 2016, to October, 2020. The patients were cared for in the hematology department of the Hospital General de Mexico and in the hematology department of the Hospital Regional de Alta Especialidad Ixtapaluca. Relapse was considered in those cases with more than 5% of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid.

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

56Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		4-years
Progression free survival		4-years
Number of relapses	Cases with more than 5 percent of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid	4-years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.

Exclusion Criteria:

Age less than 15 years
Age over 60 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Patients with first diagnosis of acute lymphoblastic leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian O Ramos-Peñafiel, MD, Ph.D	Hospital General de México Dr. Eduardo Liceaga	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Regional de Alta Especialidad de Ixtapaluca		Ixtapaluca	State of Mexico	56530	Mexico
Hospital General de México "Dr. Eduardo Liceaga"

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007938	Leukemia
D012008	Recurrence

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided