Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS
1 other identifier
interventional
100
1 country
1
Brief Summary
This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive. To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients. To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 15, 2022
June 1, 2022
15.9 years
June 2, 2011
June 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy in terms of response rate
5 years
Secondary Outcomes (1)
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
1 year
Interventions
Eligibility Criteria
You may qualify if:
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
You may not qualify if:
- Other LAL negative for t (9; 22) and Bcr / Abl.
- biphenotypic acute leukemias or bilinear with t (9; 22).
- blast crisis of chronic myeloid leukemia progression during or after polychemotherapy treatment (including allo-BMT) or with inhibitors of tyrosine kinases.
- General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- Lack of consent by the patient to use their clinical d
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Germans Trias i Pujol and all Hospital Pethema
Badalona, Barcelona, Spain
Related Publications (1)
Ribera JM, Garcia O, Fernandez-Abellan P, Lavilla E, Bernal MT, Gonzalez-Campos J, Brunet S, Monteserin MC, Montesinos P, Sarra J, Calbacho M, Alvarez-Larran A, Tormo M, Oriol A; PETHEMA Group. Lack of negative impact of Philadelphia chromosome in older patients with acute lymphoblastic leukaemia in the thyrosine kinase inhibitor era: comparison of two prospective parallel protocols. Br J Haematol. 2012 Nov;159(4):485-8. doi: 10.1111/bjh.12043. Epub 2012 Sep 12. No abstract available.
PMID: 22966847DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 20, 2011
Study Start
January 1, 2007
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
June 15, 2022
Record last verified: 2022-06