International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia linfoblástica aguda, Leucemia mieloide aguda, Trasplante de progenitores hematopoyéticos, Linfoma, Leucemia
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Marina García Morin
CENTRO INVESTIGADOR
H.U. La Paz
INVESTIGADOR PRINCIPAL
Berta González Martínez
FECHA DE APERTURA
Enero, 2021
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol.
2. > 1 year and < 21 years at ALL diagnosis
3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country.
4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib.
5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2.
7. Adequate liver function.
8. Adequate cardiac function.
9. Adequate renal function.
2. > 1 year and < 21 years at ALL diagnosis
3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country.
4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib.
5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2.
7. Adequate liver function.
8. Adequate cardiac function.
9. Adequate renal function.
CRITERIOS DE EXCLUSIÓN
1. Known history of chronic myelogenous leukemia (CML).
2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
4. Down syndrome
5. Pregnancy
6. Breast Feeding
7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol.
8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.
2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
4. Down syndrome
5. Pregnancy
6. Breast Feeding
7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol.
8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.
DESCRIPCIÓN
To compare disease-free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a highrisk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
PALABRAS CLAVE
acute lymphoblastic leukemia, donor lymphocyte infusion, leucemia linfocítica crónica (llc / cll), leukemia, ph + acute lymphoblastic leukemia, philadelphia positive acute lymphoblastic leukemia
