Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years

Not Applicable

• Conditions: Acute Lymphoblastic Leukemia Ph Positive

• Registration Number: NCT01376427
• Lead Sponsor: PETHEMA Foundation

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy in terms of response rate	5 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination	1 year

Trial Locations

Locations (1)

Hospital Germans Trias i Pujol and all Hospital Pethema; 🇪🇸 Badalona, Barcelona, Spain