Acute Lymphoblastic LeukemiaHGMHRAEI/ALLNCT04699162
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by Christian Omar Ramos-Peñafiel, MD, PhD at 2 sites in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 56 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Jul 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with first diagnosis of acute lymphoblastic leukemia
Who may be able to join
- Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.
Who cannot join
- Age less than 15 years
- Age over 60 years
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital Regional de Alta Especialidad de Ixtapaluca
Ixtapaluca, State of Mexico, 56530
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720
About this study
Official title: Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia. Experience of Two Centers in Mexico City
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
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Survival, Leukemia, Relapse, Retrospective study
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 4-years
Progression free survival
Measured: 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
Measured: 4-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jul 2016
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Omar Ramos-Peñafiel, MD, PhD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Christian O Ramos-Peñafiel, MD, Ph.D, Principal investigator, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699162
- Sponsor's protocol ID
- DECS/JPO-CT-397-2020
- Acronym
- HGMHRAEI/ALL
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia. Experience of Two Centers in Mexico City
- ClinicalTrials.gov ID
- NCT04699162
- Acronym / sponsor ID
- HGMHRAEI/ALL / DECS/JPO-CT-397-2020
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Survival, Leukemia, Relapse, Retrospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Christian Omar Ramos-Peñafiel, MD, PhDOther government
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with first diagnosis of acute lymphoblastic leukemia
Key inclusion criteria (1 listed)
- Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.
Key exclusion criteria (2 listed)
- Age less than 15 years
- Age over 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 4-years
Progression free survival
Time frame: 4-years
Number of relapses
Time frame: 4-years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian O Ramos-Peñafiel, MD, Ph.D principal investigator
Hospital General de México Dr. Eduardo Liceaga
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Christian Omar Ramos-Peñafiel, MD, PhD at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 4-years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.