Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01376427 |
| Other study ID # |
LAL-07OPH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2007 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
June 2022 |
| Source |
PETHEMA Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
