Chemotherapy and Imatinib in Young Adults With Acute Lymphoblastic Leukemia Ph (BCR-ABL) POSITIVE
NCT ID: NCT01491763
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2008-01-31
2022-12-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Imatinib
600 mg p.o. from day 1 until consolidation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Locations
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H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol and all Hospital Pethema
Badalona, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital general de Castellón
Castelló, Castellón, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General de Albacete
Albacete, , Spain
Hospital de Alcorcón
Alcorcón, , Spain
Hospital General de Alicante.
Alicante, , Spain
Hospital de Cabueñes
Asturias, , Spain
Hospital de Badalona Germans Trias i Pujol
Badalona, , Spain
Hospital Clinic y Provincial de Barcelona
Barcelona, , Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau.
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau.
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital de la santa Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Duran i Reynals - ICO L'Hospitalet
Barcelona, , Spain
Basurtuko Ospitalea
Basurto, , Spain
Complejo Hospitalario de Cáceres
Cáceres, , Spain
Complejo Hospitalario Reina Sofía
Córdoba, , Spain
Area Hospitalaria Juan Ramón Jimenez
Huelva, , Spain
Hospital Juan Ramón Jiménez
Huelva, , Spain
Hospital del SAS de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital general de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Complexo Hospitalario Xeral-Calde
Lugo, , Spain
Clínica La Concepción
Madrid, , Spain
Clínica Puerta de Hierro
Madrid, , Spain
Hospital 12 de Octubre. Madrid
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clínico San Carlos de Madrid
Madrid, , Spain
Hospital Clínico San Carlos de Madrid
Madrid, , Spain
Hospital de Fuenlabrada
Madrid, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital de Madrid, S.A.- Norte Hospital General
Madrid, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Princcipe de Asturias
Madrid, , Spain
Althaia, Xarxa Asistencial de Manresa
Manresa, , Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital de Mérida
Mérida, , Spain
Hospital General Univeristario Morales Messeguer
Murcia, , Spain
Hospital Sta. Maria del Rosell
Murcia, , Spain
Hospital del Río Carrión
Palencia, , Spain
Hospital de Gran Canaria Doctor Negrín
Palma de Gran Canaria, , Spain
Clínica Universitaria de Navarra
Pamplona, , Spain
Hospital de Montecelo
Pontevedra, , Spain
Corporació Sanitaria Parc Taulí
Sabadell, , Spain
Hospital Clínico de Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Hospital Clínico Universitario
Salamanca, , Spain
Hospital de Donostia
San Sebastián, , Spain
Hoaspital Marqués de Valdecilla
Santander, , Spain
Hospital General de Segovia
Segovia, , Spain
Complejo Hospitalario Regional Virgen del Rocío
Seville, , Spain
Hospital Joan XIII de
Tarragona, , Spain
Hospital Joan XXIII
Tarragona, , Spain
Hospital Clínico de Valencia.
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario
Valencia, , Spain
Hospital Clínic
Valencia, , Spain
Hospital Dr Pesset
Valencia, , Spain
Hospital La Fe
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Complejo Hospitalario Xeral-Cies
Vigo, , Spain
Hospital do Meixoeiro
Vigo, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Bosch LLobet, Dr
Role: primary
González Brito Gloria, Dr
Role: primary
García Raimundo, Dr
Role: primary
Bello José Luis, Dr
Role: primary
Prosper Felipe, Dr
Role: primary
Perez Equiza Encarnación, Dr
Role: primary
Carrera Dolores, Dr
Role: primary
Peñalver Francisco, Dr
Role: primary
Rivas Concha, Dra
Role: primary
Esteve Jordi, Dr
Role: primary
Rovira Montse, Dr
Role: primary
Sierra Jordi, Dr
Role: primary
Jordi Sierra, Dr
Role: primary
Delgado Julio, Dr
Role: primary
Salar Antonio, Dr
Role: primary
Besses Carles, Dr
Role: primary
Dr. Rafael Duarte Palomino, Dr
Role: primary
Beltran de Heredia José Mª, Dr
Role: primary
Bergua Juan Miguel, Dr
Role: primary
Torres Antonio, Dr
Role: primary
Fernández Antonio, Dr
Role: primary
Fernández Antonio, Dr
Role: primary
Angel León, Dr
Role: primary
León Angel, Dr
Role: primary
Sanchez Juan Manuel, Dr
Role: primary
Román Alejandro, Dr
Role: primary
Nicolás Manuel, Dr
Role: primary
Lahuerta juan José, Dr
Role: primary
Martínez Rafael, Dr
Role: primary
Del Potro Eloy, Dr
Role: primary
Diaz Mediavilla Joaquin, Dr
Role: primary
Adrián Alegre, Dr
Role: primary
Pintado Tomás, Dr
Role: primary
Blanchard Mª Jesús, Dr
Role: primary
De la Cámara Rafael, Dr
Role: primary
Gema Ramirez
Role: primary
Cuesta Angeles, Dr
Role: primary
Bethancourt Concepción, Dr
Role: primary
Barrios Manuel, Dr
Role: primary
Felipe de Arriba, Dr
Role: primary
Ortega Frenando, Dr
Role: primary
Javier Pérez Calvo, Dr
Role: primary
San Miguel Jesús, Dr
Role: primary
Mateos Maria Victoria, Dr
Role: backup
Hernández Rivas José Mª, Dr
Role: primary
Mª Consuelo del Cañizo, Dr
Role: primary
Marín Julián, Dr
Role: primary
Conde Eulogio, Dr
Role: primary
Hernandez José, Dr
Role: primary
Martín Sánchez Jesús, Dr
Role: primary
Natalia Rodriguez, Dr
Role: primary
Escoda Lourdes, Dr
Role: primary
Tormo Mar, Dra
Role: primary
Solano Carlos, Dr
Role: primary
Hernández Juan Carlos, Dr
Role: primary
Terol Maria José, Dr
Role: primary
Ferrer Secundino, Dr
Role: primary
Rafecas Javier, Dr
Role: primary
Poderós Concepción, Dr
Role: primary
Guinea Josep Mª, Dr
Role: primary
Olivé Maite, Dr
Role: primary
References
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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.
Related Links
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Pethema Foundation
Other Identifiers
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LAL Ph-2008
Identifier Type: -
Identifier Source: org_study_id
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