Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS
NCT ID: NCT01540812
Last Updated: 2020-03-09
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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COMPLETED
418 participants
OBSERVATIONAL
2012-02-29
2019-12-01
Brief Summary
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1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.
2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration
3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making.
For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy.
Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second.
Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud
Vincristine in induction:5 mg/m2 i.v. days 1, 8, 15 and 22 in induction phase Daunorubicin in induction 45 mg/m2 i.v. days 1, 8, 15 and 22 Prednisone in induction: 60 mg/m2/ day, i.v. o p.o., days 1 to 14; 30 mg/m2/day, i.v. o p.o., days 15 to 21; 15 mg/m2/day i.v. o p.o., days 21 to 28 Metotrexato 12 mg days 1 and 22 (intrathecal) Cytarabine (ARA-C): 30 mg days 1 and 22 (intrathecal) Hydrocortisone: 20 mg days 1 and 22 (intrathecal) Idarubicin-induction 2 12 mg/m2, i.v., days 1, 3 and 5 Fludarabine in induction-2: Fludarabine 30 mg/m2, i.v., days, 1 to 5
Vincristine in induction
Daunorubicin in induction
Prednisone in induction
Metotrexato in induction
Cytarabine in induction
Hydrocortisone in induction
Idarubicin in induction-2
Fludarabine in induction-2
Ara-C in induction-2
G-CSF in induction-2
Dexamethasone in consolidation-1
Vincristrine in consolidation-1
Metotrexato in consolidation-1
PEG-ASP in consolidation-1
Dexamethasone in consolidation-2
ARA-C in consolidation-2
PEG-ASP in consolidation-2
Dexamethasone in consolidation-3
Vincristine in consolidation-3
Metotrexato in consolidation-3
PEG-ASP in consolidation-3
allogeneic HSCT
Allo HSCT with reduced-intensity conditioning
Interventions
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Vincristine in induction
Daunorubicin in induction
Prednisone in induction
Metotrexato in induction
Cytarabine in induction
Hydrocortisone in induction
Idarubicin in induction-2
Fludarabine in induction-2
Ara-C in induction-2
G-CSF in induction-2
Dexamethasone in consolidation-1
Vincristrine in consolidation-1
Metotrexato in consolidation-1
PEG-ASP in consolidation-1
Dexamethasone in consolidation-2
ARA-C in consolidation-2
PEG-ASP in consolidation-2
Dexamethasone in consolidation-3
Vincristine in consolidation-3
Metotrexato in consolidation-3
PEG-ASP in consolidation-3
allogeneic HSCT
Allo HSCT with reduced-intensity conditioning
Eligibility Criteria
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Inclusion Criteria
* Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)
* No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome
* General condition suitable scale (ECOG 0-2), or\> 2 if due to ALL
* Negative pregnancy test for women of childbearing age
* Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them
Exclusion Criteria
* LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).
* Lymphoid blast crisis of chronic myeloid leukemia
* Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group
* Undifferentiated acute leukemias
* Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines
* Patients with chronic phase of activity
* Patients with severe chronic respiratory failure
* Kidney failure due to ALL
* Serious neurological disorder not due to the LAL
* History of pancreatitis
* Pregnancy or breastfeeding
* Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study
* General condition affected, not attributable to the ALL
15 Years
60 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Locations
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Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Countries
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References
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Ribera JM, Morgades M, Ciudad J, Montesinos P, Esteve J, Genesca E, Barba P, Ribera J, Garcia-Cadenas I, Moreno MJ, Martinez-Carballeira D, Torrent A, Martinez-Sanchez P, Monsalvo S, Gil C, Tormo M, Artola MT, Cervera M, Gonzalez-Campos J, Rodriguez C, Bermudez A, Novo A, Soria B, Coll R, Amigo ML, Lopez-Martinez A, Fernandez-Martin R, Serrano J, Mercadal S, Cladera A, Gimenez-Conca A, Penarrubia MJ, Abella E, Vall-Llovera F, Hernandez-Rivas JM, Garcia-Guinon A, Bergua JM, de Rueda B, Sanchez-Sanchez MJ, Serrano A, Calbacho M, Alonso N, Mendez-Sanchez JA, Garcia-Boyero R, Olivares M, Barrena S, Zamora L, Granada I, Lhermitte L, Feliu E, Orfao A. Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome-negative adult lymphoblastic leukemia. Blood. 2021 Apr 8;137(14):1879-1894. doi: 10.1182/blood.2020007311.
Other Identifiers
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LAL-AR/2011
Identifier Type: -
Identifier Source: org_study_id
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