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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01376427
Enrollment
100
Registered
2011-06-20
Start date
2007-01-31
Completion date
2022-12-31
Last updated
2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia Ph Positive

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

Interventions

DRUGDexamethasone

Dexamethasone

DRUGMethotrexate

Methotrexate

DRUGVincristine

Vincristine

Sponsors

PETHEMA Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Efficacy in terms of response rate5 years

Secondary

MeasureTime frame
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026