Acute Lymphoblastic LeukemiaPhase 4NCT01358201
PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
A Phase 4 study testing vINCRISTINE, Dexamethasone and Methotrexate in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 75 sites in Spain.
Trial summary
The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- vINCRISTINE, Dexamethasone and Methotrexate
- How many people
- 100 participants
- Where
- 75 sitesSpain
- Study dates
- May 2010to Dec 2022
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'negative and not previously treated with frailty (> 3 points in the Charlson comorbidity index)
Who cannot join
- LAL
- 1. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]).
- 2 . biphenotypic acute leukemias and bilinear 3 . acute undifferentiated leukemia 4 . Patients with a Charlson comorbidity index less than or equal to 3 (and therefore that could potentially benefit from more intensive treatment PETHEMA LAL-07OLD).
- 5 . General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- 6 . LAL Ph 'positive (though still must register their LAL07OPH specific protocol).
- 7 . Lack of consent by the patient to use their clinical data
Trial locations and contacts
75 sites in 1 country.
Josep Mª Ribera, Dr contact
75 sites in 1 country
Spain75 sites, 75 recruiting
- Recruiting
Hospital Juan Canalejo
A Coruña
Deben Guillermo, Dr
Deben Guillermo, Dr
- Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete
Santiago José, Dr
- Recruiting
Fundación Hospital Alcorcón
Alcorcón
Peñalver Francisco Javier, Dr
- Recruiting
Hospital de Alcorcón
Alcorcón
Peñalver Francisco, Dr
Peñalver Francisco, Dr
- Recruiting
Hoapital General
Alicante
Fernandez Abellan Pascual, Dr
- Recruiting
Hospital General de Alicante
Alicante
Rivas Concepción, Dr
- Recruiting
Hospital General de Alicante
Alicante
Fernández Abellán Pascual, Dr
Fernández Abellán Pascual, Dr
- Recruiting
Hospital Germans Trias i Pujol
Badalona
Ribera Josep Mª, Dr
Ribera Josep Mª, Dr
- Recruiting
Hospital Clinic y Provincial de Barcelona
Barcelona
Esteve Jordi, Dr
Esteve Jordi, Dr
- Recruiting
Hospital de la Santa Creu i Sant Pau.
Barcelona
Sierra Jordi, Dr
- Recruiting
Hospital del Mar
Barcelona
Abella Eugenia, Dr
- Recruiting
Hospital Valle Hebrón
Barcelona
Bueno Javier, Dr
- Recruiting
Institut Català d'oncología
Barcelona
Boqué Concha, Dr
Boqué Concha, Dr
- Recruiting
Basurtuko Ospitalea
Basurto
Beltran de Heredia José Mª, Dr
Beltran de Heredia Jose Mª, Dr
- Recruiting
Hospital de Cruces
Bilbao
Amutio Díez Elena, Dr
- Recruiting
Complejo Hospitalario de Cáceres
Cáceres
Bergua Juan Miguel, Dr
Bergua Juan Miguel, Dr
- Recruiting
Complejo Hospitalario Reina Sofía
Córdoba
Torres Antonio, Dr
Torres Antonio, DR
- Recruiting
Area Hospitalaria Juan Ramón Jimenez
Huelva
Fernández Antonio, Dr
Fernández Antonio, Dr
- Recruiting
Hospital Médico Quirúrgico Ciudad de Jaén
Jaén
Alcala Antonio, Dr
Alcalá Antonio, Dr
- Recruiting
H. de Jerez
Jerez de la Frontera
José Luis Guzmán Zamudio, Dr
Guzmán Zamudio José Luis, Dr
- Recruiting
Complejo Hospitalario León
León
Fuertes Nuñez Marta, Dr
- Recruiting
Hospital Arnau de Vilanova
Lleida
Sanchez Juan Manuel, Dr
Sanchez Juan Manuel, Dr
- Recruiting
Complexo Hospitalario Xeral-Calde
Lugo
Arias Jesús, Dr
- Recruiting
Clínica La Concepción
Madrid
Román Alejandro, Dr
Román Alejandro, Dr
- Recruiting
Clínica Puerta de Hierro
Madrid
Krisnk Isabel, Dr
- Recruiting
Clínica Rúber
Madrid
Martínez Carmen, Dr
- Recruiting
Fundación Jiménez Díaz
Madrid
Prieto Elena, Dr
- Recruiting
Hospital 12 de Octubre. Madrid
Madrid
Lahuerta juan José, Dr
Lahuerta Juan José, Dr
- Recruiting
Hospital Clinico San Carlos
Madrid
Martínez Rafael, Dr
Martinez Rafael, Dr
- Recruiting
Hospital Clínico San Carlos de Madrid
Madrid
Diaz Mediavilla Joaquin, Dr
Díaz Mediavilla Joaquín, Dr
- Recruiting
Hospital de Fuenlabrada
Madrid
Hernández Rivas José Angel, Dr
Hernández Rivas José Angel, Dr
- Recruiting
Hospital de la Princesa
Madrid
Adrián Alegre, Dr
Alegre Adrián, Dr
- Recruiting
Hospital de Madrid, S.A.- Norte Hospital General
Madrid
Pérez de Oteyza Jaime, Dr
- Recruiting
Hospital La Paz
Madrid
Canales Miguel Ángel, Dr
Canales Miguel Angel, Dr
- Recruiting
. Hospital Clínico Universitario Virgen de la Victoria
Málaga
Moreno Mª José, Dr
- Recruiting
Complejo Hospital Costa del Sol
Málaga
María Casanova Espinosa, Dr
Casanova Espinosa María, Dr
- Recruiting
H. Carlos Haya
Málaga
Negri Silvia, Dr
- Recruiting
Hospital Carlos Haya
Málaga
Barrios Manuel, Dr
Barrios Manuel, Dr
- Recruiting
Althaia, Xarxa Asistencial de Manresa
Manresa
Subira Maricel, Dr
- Recruiting
Fundación Hospital Sant Joan de Déu de Martorell
Martorell
Las Heras German, Dr
- Recruiting
Hospital General Morales Meseguer
Murcia
De Arriba Felipe, Dr
- Recruiting
Hospital Morales Messeguer. Murcia
Murcia
Amigo Mª Luz, Dr
Amigo Mª Luz, Dr
- Recruiting
Hospital Sta. Maria del Rosell
Murcia
Ibañez Jerónima, Dr
- Recruiting
Hospital Central de Asturias
Oviedo
Rayón MC, Dr
- Recruiting
Hospital del Río Carrión
Palencia
Ortega Frenando, Dr
Ortega Fernando, Dr
- Recruiting
H. Son Llatzer
Palma de Mallorca, Balearic Islands
Bargay Lleoneart Joan, Dr
- Recruiting
Complejo Asistencial Son Dureta
Palma de Mallorca
Sampol Antonia
- Recruiting
Clínica Universitaria de Navarra
Pamplona, Navarre
Prosper Felipe, Dr
Prosper Felipe, Dr
- Recruiting
Complejo Hospitalario de Pontevedra_Hospital Montecelo
Pontevedra
Allegue Mª José, Dr
- Recruiting
Complejo Hospitalario de Pontevedra_Hospital Provincial
Pontevedra
Constela Manuel, Dr
- Recruiting
Corporació Sanitaria Parc Taulí
Sabadell
Rámila Elena, Dr
- Recruiting
Hospital Clinico Universitario
Salamanca
Del Cañizo Consuelo, Dr
- Recruiting
Hospital Clínico de Salamanca
Salamanca
San Miguel Jesús, Dr
Mateos Maria Victoria, Dr
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
Hernández Rivas Jesús Mª, Dr
Hernández Rivas Jesús Mª, Dr
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
Mateos Mª Victoria, Dr
Mateos Mª Victoria, Dr
- Recruiting
Clínica Sant Camil
Sant Pere de Ribes
Asensio Antonio, Dr
- Recruiting
Hoaspital Marqués de Valdecilla
Santander
Conde Eulogio, Dr
- Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Bello Jose Luis, Dr
- Recruiting
Hospital General de Segovia
Segovia
Hernández José Mariano
- Recruiting
Complejo Hospitalario Regional Virgen del Rocío
Seville
Martín Sánchez Jesús, Dr
Martin Sanchez Jesús, Dr
- Recruiting
Hospital Joan XXIII
Tarragona
Escoda Lourdes, Dr
Escoda Lourdes
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona
- Recruiting
Fundación Instituto Valenciano de Oncología
Valencia
Llorente Pablo, Dr
- Recruiting
Hoapital La Fe
Valencia
Sanz Miguel Angel, Dr, 96 386 27 58, msanz@uv.es
- Recruiting
Hospital Clínico de Valencia.
Valencia
Tormo Mar, Dra
Teruel Casasús Ana Isabel, Dr
- Recruiting
Hospital Clínico de Valencia
Valencia
Tormo Mar, Dr
- Recruiting
Hospital Clínic
Valencia
Terol Maria José, Dr
Terol Mª José, Dr
- Recruiting
Hospital Dr Pesset
Valencia
Ferrer Secundino, Dr
Ferrer Secundino, Dr
- Recruiting
Hospital General
Valencia
Carbonell Félix, Dr
Carbonell Félix, Dr
- Recruiting
Hospital La Fe
Valencia
De la Rubia Javier, Dr, delarubia_jav@gva.es
De la Rubia Javier, Dr
- Recruiting
Hospital Clínico de Valladolid
Valladolid
Fernandez Calvo Francisco, Dr
- Recruiting
Complejo Hospitalario Universitario de Vigo
Vigo
Poderós Concepción, Dr
- Recruiting
Comarcal de Vinaros
Vinaròs
Montagud Mario, Dr
- Recruiting
Hospital Clinico Lozano Blesa
Zaragoza
Palomera Bernal Luis, Dr
- Recruiting
Hospital Lozano Blesa. Zaragoza
Zaragoza
Olave Mª Teresa, Dr
Olave Mª Teresa, Dr
About this study
Official title: Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years
The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity
Read the detailed description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function.
Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.
Remission induction :
Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction.
Systemic treatment
- Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
- Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23.
Intrathecal chemotherapy
Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction):
MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg
If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial
Maintenance treatment of first year :
Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission.
The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.
Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting
- VCR: 1 mg (absolute dose), i.v., day 1.
- Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
- Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.
Maintenance of the second year:
After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.
The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- vINCRISTINE, Dexamethasone, Methotrexate, Cytosine arabinoside
- Keywords
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vINCRISTINEDrug
DexamethasoneDrug
MethotrexateDrug
Cytosine arabinosideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of response rate
Measured: 5 years
Secondary outcomes (2)
Efficacy in terms disease free survival
Measured: 5 years
Efficacy in terms of global survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT01358201
- Sponsor's protocol ID
- PETHEMA LAL-07FRAIL
- Status last verified
- Jan 2022
- First submitted
- 18 May 2011
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years
- ClinicalTrials.gov ID
- NCT01358201
- Acronym / sponsor ID
- PETHEMA LAL-07FRAIL
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 May 2011 (estimated)
- 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 biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity
Detailed description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function.
Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.
Remission induction :
Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction.
Systemic treatment
- Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
- Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23.
Intrathecal chemotherapy
Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction):
MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg
If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial
Maintenance treatment of first year :
Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission.
The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.
Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting
- VCR: 1 mg (absolute dose), i.v., day 1.
- Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
- Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.
Maintenance of the second year:
After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.
The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'negative and not previously treated with frailty (> 3 points in the Charlson comorbidity index)
Key exclusion criteria (6 listed)
- LAL
- 1. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]).
- 2 . biphenotypic acute leukemias and bilinear 3 . acute undifferentiated leukemia 4 . Patients with a Charlson comorbidity index less than or equal to 3 (and therefore that could potentially benefit from more intensive treatment PETHEMA LAL-07OLD).
- 5 . General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- 6 . LAL Ph 'positive (though still must register their LAL07OPH specific protocol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vINCRISTINE | Drug | – |
| Dexamethasone | Drug | – |
| Methotrexate | Drug | – |
| Cytosine arabinoside | Drug | – |
Primary outcome
Efficacy in terms of response rate
Time frame: 5 years
2 secondary outcomes
Efficacy in terms disease free survival
Time frame: 5 years
Efficacy in terms of global survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Pethema FoundationLink provided by the sponsor.
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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.
Josep Mª Ribera, Dr contact
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vINCRISTINE, Dexamethasone and Methotrexate in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 75 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 6 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Josep Mª Ribera, Dr (jribera@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in terms of response rate (time frame: 5 years). 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 19 Jan 2022.