Description:
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
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
LAL-07OPH
- NCT ID:
NCT01376427
Conditions
- Acute Lymphoblastic Leukemia Ph Positive
Interventions
Drug | Synonyms | Arms |
---|
Dexamethasone | | |
Methotrexate | | |
Vincristine | | |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Eligibility Criteria
Inclusion Criteria:
Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl
positive) and previously untreated
Exclusion Criteria:
1. Other LAL negative for t (9; 22) and Bcr / Abl.
2. biphenotypic acute leukemias or bilinear with t (9; 22).
3. 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
4. General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
5. Lack of consent by the patient to use their clinical d
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 55 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Efficacy in terms of response rate |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | PETHEMA Foundation |
Last Updated
January 15, 2021