Acute Lymphoblastic Leukemia Ph PositivePhase 4NCT01491763
Chemotherapy and Imatinib in Young Adults With Acute Lymphoblastic Leukemia Ph (BCR-ABL) POSITIVE
A Phase 4 study testing Imatinib in people with Acute Lymphoblastic Leukemia Ph Positive, run by PETHEMA Foundation at 81 sites in Spain.
Trial summary
20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic treatment of this disease, but the results have been poor… Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia Ph Positive
- What is being tested?
- Imatinib
- How many people
- 70 participants
- Where
- 81 sitesSpain
- Study dates
- Jan 2008to 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 Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with Ph (BCR/ABL) positive de novo < 55 years old (it is advisable to include patients over 55 years LAL07OPH protocol).
- Performance status 0-2 (Appendix B) may include patients with performance status > 2 attributable to LAL.
- Patients without functional impairment of organs: liver function: total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine > 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF > 50%, absence of severe chronic respiratory disease. In the event that alterations are secondary to the disease is at the discretion of the investigator to determine if the patient can be included in the trial.
Who cannot join
- Any other variety of LAL
- Patients with a history of coronary artery disease, valvular or hypertensive heart disease
- Patients with chronic liver disease
- Patients with chronic respiratory failure
- Renal failure not due to LAL
- Patients with positive HIV status
Show all 10Show fewer
- No serious neurological abnormalities due to LAL
- Impact on overall severe (grade 3 or 4 of the WHO scale) not attributable to the LAL
- Pregnant or breastfeeding
- initial blast crisis CML
Trial locations and contacts
81 sites in 1 country.
81 sites in 1 country
Spain81 sites, 81 recruiting
- Recruiting
Hospital General de Albacete
Albacete
- Recruiting
Hospital de Alcorcón
Alcorcón
Peñalver Francisco, Dr
Peñalver Francisco, Dr
- Recruiting
Hospital General de Alicante.
Alicante
Rivas Concha, Dra
- Recruiting
Hospital de Cabueñes
Asturias
- Recruiting
Hospital Germans Trias i Pujol and all Hospital Pethema
Badalona, Barcelona
Jose Mª Ribera, Dr, jribera@iconcologia.net
- Recruiting
Hospital de Badalona Germans Trias i Pujol
Badalona
Oriol Albert, DR
- Recruiting
Hospital Clinic y Provincial de Barcelona
Barcelona
Esteve Jordi, Dr
Esteve Jordi, Dr
- Recruiting
Hospital Clínico y Provincial de Barcelona
Barcelona
Rovira Montse, Dr
Rovira Montse, Dr
- Recruiting
Hospital de la Santa Creu i Sant Pau.
Barcelona
Sierra Jordi, Dr
- Recruiting
Hospital de la Santa Creu i Sant Pau.
Barcelona
Jordi Sierra, Dr
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Sureda Anna, Dr, asureda@hsp.santpau.es
- Recruiting
Hospital de la santa Creu i Sant Pau
Barcelona
Delgado Julio, Dr
Delgado Julio, Dr
- Recruiting
Hospital del Mar
Barcelona
Abella Eugenia, Dr
- Recruiting
Hospital del Mar
Barcelona
Salar Antonio, Dr
Salar Antonio, Dr
- Recruiting
Hospital del Mar
Barcelona
Besses Carles, Dr
Besses Carles, Dr
- Recruiting
Hospital Duran i Reynals - ICO L'Hospitalet
Barcelona
Dr. Rafael Duarte Palomino, Dr
- Recruiting
Basurtuko Ospitalea
Basurto
Beltran de Heredia José Mª, Dr
Beltran de Heredia Jose Mª, Dr
- Recruiting
Complejo Hospitalario de Cáceres
Cáceres
Bergua Juan Miguel, Dr
Bergua Juan Miguel, Dr
- Recruiting
Hospital general de Castellón
Castelló, Castellón
García Raimundo, Dr
Garcia Raimundo, 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 Juan Ramón Jiménez
Huelva
Fernández Antonio, Dr
Fernández Antonio, Dr
- Recruiting
Hospital del SAS de Jerez de la Frontera
Jerez de la Frontera
Angel León, Dr
- Recruiting
Hospital general de Jerez de la Frontera
Jerez de la Frontera
León Angel, Dr
León Angel, 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
Nicolás Manuel, Dr
Nicolás Manuel, 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
Del Potro Eloy, Dr
Del Potro Eloy, Dr
- Recruiting
Hospital Clínico San Carlos de Madrid
Madrid
Diaz Mediavilla Joaquin, Dr
Díaz Mediavilla Joaquín, Dr
- Recruiting
Hospital de Fuenlabrada
Madrid
Bravo Barahona Pilar, 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 Gregorio Marañón
Madrid
Pintado Tomás, Dr
Pintado Tomás, Dr
- Recruiting
Hospital Ramón y Cajal
Madrid
Blanchard Mª Jesús, Dr
Blanchard Mª Jesús, Dr
- Recruiting
Hospital Universitario de la Princesa
Madrid
De la Cámara Rafael, Dr
de la Cámara Rafael, Dr
- Recruiting
Hospital Universitario Princcipe de Asturias
Madrid
Burgaleta Carmen, Dr
- Recruiting
. Hospital Clínico Universitario Virgen de la Victoria
Málaga
Moreno Mª José, Dr
- Recruiting
. Hospital Clínico Universitario Virgen de la Victoria
Málaga
Gema Ramirez
Ramirez Gema, Dr
- Recruiting
Hospital Carlos Haya
Málaga
Cuesta Angeles, Dr
Cuesta Angeles, Dr
- Recruiting
Hospital Carlos Haya
Málaga
Bethancourt Concepción, Dr
Bethancourt Concepción, Dr
- Recruiting
Hospital Carlos Haya
Málaga
Barrios Manuel, Dr
Barrios Manuel, Dr
- Recruiting
Althaia, Xarxa Asistencial de Manresa
Manresa
Subira Maricel, Dr
- Recruiting
Hospital de Mataró
Mataró, Barcelona
Bosch LLobet, Dr
Bosch Alba, Dr
- Recruiting
Hospital de Mérida
Mérida
Lopez Carlos, Dr
- Recruiting
Hospital General Univeristario Morales Messeguer
Murcia
Felipe de Arriba, Dr
de Arriba Felipe, Dr
- Recruiting
Hospital Sta. Maria del Rosell
Murcia
Ibañez Jerónima, Dr
- Recruiting
Hospital Central de Asturias
Oviedo, Principality of Asturias
Carrera Dolores, Dr
Carrera Dolores, Dr
- Recruiting
Hospital del Río Carrión
Palencia
Ortega Frenando, Dr
Ortega Fernando, Dr
- Recruiting
Hospital de Gran Canaria Doctor Negrín
Palma de Gran Canaria
Suarez Alexia, Dr
- Recruiting
H. Son Llatzer
Palma de Mallorca, Balearic Islands
Bargay Lleoneart Joan, Dr
- Recruiting
Clínica Universitaria de Navarra
Pamplona, Navarre
Prosper Felipe, Dr
Prosper Felipe, Dr
- Recruiting
Hospital de Navarra
Pamplona, Navarre
Perez Equiza Encarnación, Dr
Perez Equiza Encarnación, Dr
- Recruiting
Clínica Universitaria de Navarra
Pamplona
Javier Pérez Calvo, Dr
Javier Pérez Calvo, Dr
- Recruiting
Hospital de Montecelo
Pontevedra
Allegue Mª Jose, Dr
- Recruiting
Corporació Sanitaria Parc Taulí
Sabadell
Rámila Elena, Dr
- Recruiting
Hospital Clínico de Salamanca
Salamanca
San Miguel Jesús, Dr
Mateos Maria Victoria, Dr
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
Hernández Rivas José Mª, Dr
Hernández Rivas José Mª, Dr
- Recruiting
Hospital Clínico Universitario
Salamanca
Mª Consuelo del Cañizo, Dr
Mª Consuelo del Cañizo, Dr
- Recruiting
Hospital de Donostia
San Sebastián
Marín Julián, Dr
Marín Julián, Dr
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands
González Brito Gloria, Dr
Gonzalez brito Gloria, Dr
- Recruiting
Hoaspital Marqués de Valdecilla
Santander
Conde Eulogio, Dr
Conde Eulogio, Dr
- Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña
Bello José Luis, Dr
Bello José Luis, Dr
- Recruiting
Hospital General de Segovia
Segovia
Hernandez José, Dr
Hernández José, Dr
- Recruiting
Complejo Hospitalario Regional Virgen del Rocío
Seville
Martín Sánchez Jesús, Dr
Martin Sanchez Jesús, Dr
- Recruiting
Hospital Joan XIII de
Tarragona
Natalia Rodriguez, Dr
Natalia Rodriguez, Dr
- Recruiting
Hospital Joan XXIII
Tarragona
Escoda Lourdes, Dr
Escoda Lourdes
- Recruiting
Hospital Clínico de Valencia.
Valencia
Tormo Mar, Dra
Teruel Casasús Ana Isabel, Dr
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Solano Carlos, Dr
Solano Carlos, Dr
- Recruiting
Hospital Clínico Universitario
Valencia
Hernández Juan Carlos, Dr
Hernández Juan Carlos, 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 La Fe
Valencia
De la Rubia Javier, Dr, delarubia_jav@gva.es
De la Rubia Javier, Dr
- Recruiting
Hospital Universitario Dr. Peset
Valencia
Rafecas Javier, Dr
Rafecas Javier, Dr
- Recruiting
Hospital Clínico de Valladolid
Valladolid
Fernandez Calvo Francisco, Dr
- Recruiting
Complejo Hospitalario Xeral-Cies
Vigo
Poderós Concepción, Dr
Poderós Concepción, Dr
- Recruiting
Hospital do Meixoeiro
Vigo
- Recruiting
Hospital Txagorritxu
Vitoria-Gasteiz
Guinea Josep Mª, Dr
Guinea José Mª, Dr
- Recruiting
Hospital Clínico Lozano Blesa
Zaragoza
Olivé Maite, Dr
Olivé Maite, Dr
About this study
20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and probability of long-term survival less than 20%). The effectiveness of imatinib for hematologic responses in patients with Ph + (observed in phase I and II) led to its use in phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly higher than historical controls with the same chemotherapy without imatinib. This led to the approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for Ph + in combination with chemotherapy.
Of the studies that led to the approval of this indication for imatinib, and other incurred after, the following conclusions can be drawn:
Read more
There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and chemotherapy. However, when compared with concomitant alternating with the first achieved a higher rate of RM at the end of induction, although this did not influence DFS.
In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to achieve CR in young patients with minimal toxicity, which further compromises the administration of treatment and allow for an allogeneic HSCT with minimal toxic load possible.
Although there is no consensus on the indication of allogeneic HSCT in first CR when given imatinib associated with intensive chemotherapy is an option that is done in most studies.
The allogeneic HSCT is most effective when carried out in complete molecular response to or greater than when there is more residual disease. However, the impact of MRI to obtain early (after induction) on survival is not clear. So far-reaching goal is to make the TPH in complete molecular response situation or greater.
The relapse of the disease at the molecular level is still short-term (less than 3 months) of hematological relapse. This implies the need for frequent monitoring of residual disease (ER) The frequency of relapse post HSCT is high (around 30%), raising the need for any post HSCT treatment, including imatinib included. Are currently ongoing clinical trials comparing the systematic administration of imatinib after administration TPH face is detected only when ER.
The applicability of the administration of imatinib after HSCT is limited by toxicity related to the procedure of TPH, is making frequent dose reduction or discontinuation.
Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical trial is to get as many molecular responses before allogeneic HSCT in a position to make the same MRI complete or greater. After TPH, must be very close monitoring of the ER, and imatinib is administered as soon as you notice the loss of molecular response.
In patients who can not make an allogeneic HSCT for lack of histocompatible donor or contraindications for its realization it is recommended imatinib and chemotherapy, although there are studies that have undergone an autologous HSCT, followed or not treatment "maintenance" with imatinib. The low toxicity of autologous HSCT and no effect of graft versus leukemia are strongly recommended the administration of maintenance therapy with imatinib combined with chemotherapy or not.
Read the detailed description
Induction Chemotherapy
- Vincristine (VCR): 1.5 mg/m2 (maximum dose 2 mg) iv days 1, 8, 15 and 22
- daunorubicin (DNR) 45 mg/m2 i.v. days 1, 8, 15 and 22
- Prednisone (PDN): 60 mg/m2 per day, i.v. or p.o., days 1-27
- Imatinib 600 mg p.o. from day 1 until the beginning of the consolidation. Important Note: The administration of imatinib be initiated as soon as the outcome of cytogenetic and molecular study, which will be known under normal conditions during prophase consolidation
Patients should be in RC and shall be a minimum of 2 weeks of finding it. Patients did not discontinue treatment with imatinib during this period. Minimum counts to start the consolidation are: neutrophils> 1x109 / L and platelets> 100x109 / L.
- Mercaptopurine (MP) 50 mg/m2, p.o. days 1 to 7, 28 to 35 and 56 to 63
- MTX: 1.5 g/m2, i.v. continuous infusion for 24 hours on days 1, 28 and 56.
- VP-16: 100 mg/m2 every 12 hours, i.v. (1 hour infusion) on days 14 and 42
- ARA-C: 1000 mg/m2 every 12 hours, i.v. (3-hour infusion) days 14-15 and 42-43
- triple intrathecal treatment days 1, 28 and 56
- Imatinib 600 mg / d po, from day 1 to 15 days before the TPH.
During consolidation therapy is recommended in primary prophylaxis with G-CSF or found neutropenia (<0.5 x109 / L). This factor was administered daily until the neutrophil count is > 1x109 / L in two consecutive measurements. Alternatively, PEG-filgrastim can be used (eg 16 and 44), at the discretion of each center
Allogenic THP or Autologous TPH
- Conditions
- Acute Lymphoblastic Leukemia Ph Positive
- Being tested
- Imatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
600 mg p.o. from day 1 until consolidation
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of number of complete response
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 posted14 Dec 2011 (estimated)
- Study startJan 2008
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia Ph PositiveStudies 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
- 70 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
- NCT01491763
- Sponsor's protocol ID
- LAL Ph-2008
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2011
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ribera JM, Garcia O, Moreno MJ, Barba P, Garcia-Cadenas I, Mercadal S, Montesinos P, Barrios M, Gonzalez-Campos J, Martinez-Carballeira D, Gil C, Ribera J, Vives S, Novo A, Cervera M, Serrano J, Lavilla E, Abella E, Tormo M, Amigo ML, Artola MT, Genesca E, Bravo P, Garcia-Belmonte D, Garcia-Guinon A, Hernandez-Rivas JM, Feliu E; PETHEMA Group of the Spanish Society of Hematology. Incidence and outcome after first molecular versus overt recurrence in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia included in the ALL Ph08 trial from the Spanish PETHEMA Group. Cancer. 2019 Aug 15;125(16):2810-2817. doi: 10.1002/cncr.32156. Epub 2019 Apr 23.
PubMed 31012967
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
- Chemotherapy and Imatinib in Young Adults With Acute Lymphoblastic Leukemia Ph (BCR-ABL) POSITIVE
- ClinicalTrials.gov ID
- NCT01491763
- Acronym / sponsor ID
- LAL Ph-2008
- Conditions
- Acute Lymphoblastic Leukemia Ph Positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Dec 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.
20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and probability of long-term survival less than 20%). The effectiveness of imatinib for hematologic responses in patients with Ph + (observed in phase I and II) led to its use in phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly higher than historical controls with the same chemotherapy without imatinib. This led to the approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for Ph + in combination with chemotherapy.
Of the studies that led to the approval of this indication for imatinib, and other incurred after, the following conclusions can be drawn:
There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and chemotherapy. However, when compared with concomitant alternating with the first achieved a higher rate of RM at the end of induction, although this did not influence DFS.
In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to achieve CR in young patients with minimal toxicity, which further compromises the administration of treatment and allow for an allogeneic HSCT with minimal toxic load possible.
Although there is no consensus on the indication of allogeneic HSCT in first CR when given imatinib associated with intensive chemotherapy is an option that is done in most studies.
The allogeneic HSCT is most effective when carried out in complete molecular response to or greater than when there is more residual disease. However, the impact of MRI to obtain early (after induction) on survival is not clear. So far-reaching goal is to make the TPH in complete molecular response situation or greater.
The relapse of the disease at the molecular level is still short-term (less than 3 months) of hematological relapse. This implies the need for frequent monitoring of residual disease (ER) The frequency of relapse post HSCT is high (around 30%), raising the need for any post HSCT treatment, including imatinib included. Are currently ongoing clinical trials comparing the systematic administration of imatinib after administration TPH face is detected only when ER.
The applicability of the administration of imatinib after HSCT is limited by toxicity related to the procedure of TPH, is making frequent dose reduction or discontinuation.
Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical trial is to get as many molecular responses before allogeneic HSCT in a position to make the same MRI complete or greater. After TPH, must be very close monitoring of the ER, and imatinib is administered as soon as you notice the loss of molecular response.
In patients who can not make an allogeneic HSCT for lack of histocompatible donor or contraindications for its realization it is recommended imatinib and chemotherapy, although there are studies that have undergone an autologous HSCT, followed or not treatment "maintenance" with imatinib. The low toxicity of autologous HSCT and no effect of graft versus leukemia are strongly recommended the administration of maintenance therapy with imatinib combined with chemotherapy or not.
Detailed description
Induction Chemotherapy
- Vincristine (VCR): 1.5 mg/m2 (maximum dose 2 mg) iv days 1, 8, 15 and 22
- daunorubicin (DNR) 45 mg/m2 i.v. days 1, 8, 15 and 22
- Prednisone (PDN): 60 mg/m2 per day, i.v. or p.o., days 1-27
- Imatinib 600 mg p.o. from day 1 until the beginning of the consolidation. Important Note: The administration of imatinib be initiated as soon as the outcome of cytogenetic and molecular study, which will be known under normal conditions during prophase consolidation
Patients should be in RC and shall be a minimum of 2 weeks of finding it. Patients did not discontinue treatment with imatinib during this period. Minimum counts to start the consolidation are: neutrophils> 1x109 / L and platelets> 100x109 / L.
- Mercaptopurine (MP) 50 mg/m2, p.o. days 1 to 7, 28 to 35 and 56 to 63
- MTX: 1.5 g/m2, i.v. continuous infusion for 24 hours on days 1, 28 and 56.
- VP-16: 100 mg/m2 every 12 hours, i.v. (1 hour infusion) on days 14 and 42
- ARA-C: 1000 mg/m2 every 12 hours, i.v. (3-hour infusion) days 14-15 and 42-43
- triple intrathecal treatment days 1, 28 and 56
- Imatinib 600 mg / d po, from day 1 to 15 days before the TPH.
During consolidation therapy is recommended in primary prophylaxis with G-CSF or found neutropenia (<0.5 x109 / L). This factor was administered daily until the neutrophil count is > 1x109 / L in two consecutive measurements. Alternatively, PEG-filgrastim can be used (eg 16 and 44), at the discretion of each center
Allogenic THP or Autologous TPH
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with Ph (BCR/ABL) positive de novo < 55 years old (it is advisable to include patients over 55 years LAL07OPH protocol).
- Performance status 0-2 (Appendix B) may include patients with performance status > 2 attributable to LAL.
- Patients without functional impairment of organs: liver function: total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine > 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF > 50%, absence of severe chronic respiratory disease. In the event that alterations are secondary to the disease is at the discretion of the investigator to determine if the patient can be included in the trial.
Key exclusion criteria (10 listed)
- Any other variety of LAL
- Patients with a history of coronary artery disease, valvular or hypertensive heart disease
- Patients with chronic liver disease
- Patients with chronic respiratory failure
- Renal failure not due to LAL
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 |
|---|---|---|
| Imatinib600 mg p.o. from day 1 until consolidation | Drug | – |
Primary outcome
Efficacy in terms of number of complete response
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 19 Jan 2022.
- Derived from this study: PubMed 31012967Ribera JM, Garcia O, Moreno MJ, Barba P, Garcia-Cadenas I, Mercadal S, Montesinos P, Barrios M, Gonzalez-Campos J, Martinez-Carballeira D, Gil C, Ribera J, Vives S, Novo A, Cervera M, Serrano J, Lavilla E, Abella E, Tormo M, Amigo ML, Artola MT, Genesca E, Bravo P, Garcia-Belmonte D, Garcia-Guinon A, Hernandez-Rivas JM, Feliu E; PETHEMA Group of the Spanish Society of Hematology. Incidence and outcome after first molecular versus overt recurrence in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia included in the ALL Ph08 trial from the Spanish PETHEMA Group. Cancer. 2019 Aug 15;125(16):2810-2817. doi: 10.1002/cncr.32156. Epub 2019 Apr 23.
- Pethema FoundationLink provided by the sponsor.
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Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
RecruitingPhase 1/2
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Philadelphia Chromosome-Positive, Acute Lymphoblastic Leukemia
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.
81 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 Imatinib in people with Acute Lymphoblastic Leukemia Ph Positive, run by PETHEMA Foundation at 81 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 3 inclusion and 10 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 81 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 (34 93 497 89 74, 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 number of complete response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01491763, which also lists 1 linked publication.
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.