Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
Primary Purpose
Acute Lymphoblastic Leukemia Ph Positive
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dexamethasone
Methotrexate
Vincristine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia Ph Positive
Eligibility Criteria
Inclusion Criteria:
Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
Exclusion Criteria:
- 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.
The criteria for exclusion from treatment (but not patient record) any of the following
- 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
Sites / Locations
- Hospital Germans Trias i Pujol and all Hospital PethemaRecruiting
Outcomes
Primary Outcome Measures
Efficacy in terms of response rate
Secondary Outcome Measures
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01376427
Brief Title
Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
Official Title
PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2007 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1).
Intrathecal treatment (diagnosis and prophylactic / therapeutic) -5 days:
Methotrexate 12 mg
Systemic treatment:
Imatinib 400 mg daily and continuous VO.
Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. .
Intrathecal chemotherapy:
Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prophase and induction):
MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg
Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including mielograma and Bcr-Abl/Abl or Bcr-Abl/Gus ratio in peripheral blood) and will last until one year from the time of complete remission.
The basic treatment included imatinib 400 mg / day (or dasatinib), mercaptopurine at doses of 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.
One week every 3 months maintenance treatment added a "mini-reinduction" consisting
VCR: 1 mg (absolute dose), i.v., day 1.
Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.
Maintenance treatment of second year
After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.
Maintenance treatment of third year During the third year after complete remission imatinib administered alone (or dasatinib
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia Ph Positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine
Primary Outcome Measure Information:
Title
Efficacy in terms of response rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
Exclusion Criteria:
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.
The criteria for exclusion from treatment (but not patient record) any of the following
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
Facility Information:
Facility Name
Hospital Germans Trias i Pujol and all Hospital Pethema
City
Badalona
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Mª Ribera, Dr
Email
jribera@iconcologia.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
22966847
Citation
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.
Results Reference
derived
Links:
URL
https://www.fundacionpethema.es/
Description
Related Info
Learn more about this trial
Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
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