Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
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|ClinicalTrials.gov Identifier: NCT01376427|
Recruitment Status : Recruiting
First Posted : June 20, 2011
Last Update Posted : April 25, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Ph Positive||Drug: Dexamethasone Drug: Methotrexate Drug: Vincristine||Not Applicable|
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
- 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. .
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
- Efficacy in terms of response rate [ Time Frame: 5 years ]
- Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376427
|Hospital Germans Trias i Pujol and all Hospital Pethema||Recruiting|
|Badalona, Barcelona, Spain|
|Contact: Jose Mª Ribera, Dr email@example.com|