Lymphoblastic LymphomaNCT03571997
Study of Prognostic Factors in Adult Lymphoblastic Lymphoma
An observational study of Lymphoblastic Lymphoma, run by PETHEMA Foundation at 28 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoblastic Lymphoma
- How many people
- 30 participants
- Where
- 28 sitesSpain
- Study dates
- 15 Jun 2018to 30 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients> 15 years diagnosed with ALL and treated with the PETHEMA protocols for ALL
Who may be able to join
- Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL
Who cannot join
- None
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites, 28 recruiting
- Recruiting
Hospital General de Alicante
Alicante
Cristina Gil
- Recruiting
H. de la Santa Creu I Sant Pau
Barcelona
Irene García Cadenas
- Recruiting
H. Vall d'Hebron, Barcelona
Barcelona
Pere Barba
- Recruiting
H.Universitari Germans Trias I Pujol de Badalona
Barcelona
Josep Maria Ribera
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Jordi Esteve
- Recruiting
Hospital de Basurto
Basurto
Cristina Barrenetxea Lekue
- Recruiting
ICO-Duran i Reynals
Bellvitge
Santiago Mercadal
- Recruiting
Hospital Donostia
Donostia / San Sebastian
Teresa Artola
- Recruiting
H. Univ. de Girona Dr. Josep Trueta (ICO)
Girona
Rosa Coll
- Recruiting
Hospital Arnau de Vilanova (Lleida)
Lleida
Antoni Garcia-Guiñon
- Recruiting
Hospital Lucus Augusti
Lugo
María José Sánchez Sánchez
- Recruiting
H. Gregorio Marañón
Madrid
Silvia Monsalvo
- Recruiting
Hospital San Pedro de Alcántara.
Málaga
Bergua Juan, Dr
- Recruiting
Hospital General Universitario Morales Messeguer
Murcia
Maria Luz Amigo
- Recruiting
Hospital Central de Asturias
Oviedo, Principality of Asturias
Teresa Bernal
- Recruiting
Hospital Son Espases
Palma de Mallorca
Andrés Novo
- Recruiting
Hospital Son Llatzer
Palma de Mallorca
Antònia Cladera
- Recruiting
Complejo Hospitalario de Navarra
Pamplona
Maria Carmen Mateos Rodríguez
- Recruiting
Parc Taulí
Sabadell
Sonia Piernas
- Recruiting
H. Univ. de Salamanca
Salamanca
Jesús María Hernández Rivas
- Recruiting
C. H. U. de Santiago
Santiago de Compostela
Natalia Alonso, Dr
- Recruiting
Complejo Hosp. Regional Virgen del Rocío
Seville, 41013
José González Campos, Dr
- Recruiting
Hospital del Valme
Seville
Maria Ángeles Domínguez
- Recruiting
H. Joan XXIII
Tarragona
Marta Cervera
- Recruiting
Hospital Mútua de Terrassa
Terrassa, Barcelona
Ferran Vall-Llovera
- Recruiting
Hoapital La Fe
Valencia
Pau Montesinos
- Recruiting
Hospital Arnau de Vilanova (Valencia)
Valencia
Aurelio López
- Recruiting
Hospital Universitari Clínic València
Valencia
Mar Tormo
About this study
Official title: FPLLA-PETHEMA-001: Study of Prognostic Factors in Adult Lymphoblastic Lymphoma
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
Read the detailed description
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. Analysis of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL
- Conditions
- Lymphoblastic Lymphoma
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Description pronostic factors
Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL
Measured: 1 year
Secondary outcomes (2)
overall survival
To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start15 Jun 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic LymphomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571997
- Sponsor's protocol ID
- FPLLA-PETHEMA-001
- Status last verified
- Jan 2022
- First submitted
- 18 Jun 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FPLLA-PETHEMA-001: Study of Prognostic Factors in Adult Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT03571997
- Acronym / sponsor ID
- FPLLA-PETHEMA-001
- Conditions
- Lymphoblastic Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Jun 2018 (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.
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
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. Analysis of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients> 15 years diagnosed with ALL and treated with the PETHEMA protocols for ALL
Key inclusion criteria (1 listed)
- Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL
Key exclusion criteria (1 listed)
- None
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
Description pronostic factors
Time frame: 1 year
Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL
2 secondary outcomes
overall survival
Time frame: 1 year
Progression free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoblastic Lymphoma, run by PETHEMA Foundation at 28 sites in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Sagüés Serrano, Dr (972 225 158, msagues@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description pronostic factors (time frame: 1 year). 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 1 Feb 2022.