Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS
1 other identifier
observational
418
1 country
1
Brief Summary
Trial protocol intended the optimization of induction treatment with:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 9, 2020
March 1, 2020
7.8 years
February 23, 2012
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - \<0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design
2 years
Secondary Outcomes (5)
Evaluate CR rate with addition of PEG-ASP in the induction phase
2 years
Standarization of minimal residual disease
2 years
To assess the toxic mortality
2 years
Assess the proportion of non-responders or slow responders
2 years
Overall survival
5 years
Study Arms (1)
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
Interventions
Eligibility Criteria
ALL patients
You may qualify if:
- ALL de novo high-risk 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
You may not qualify if:
- L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Related Publications (1)
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.
PMID: 33150388DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
February 1, 2012
Primary Completion
November 20, 2019
Study Completion
December 1, 2019
Last Updated
March 9, 2020
Record last verified: 2020-03