Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02036489 |
| Other study ID # |
LAL-RI/2008 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 2008 |
| Est. completion date |
December 1, 2019 |
Study information
| Verified date |
March 2020 |
| Source |
PETHEMA Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL
treated with a pediatric protocol.
Description:
Induction therapy is administered. Patients experiencing slow response (> 10 % blasts in the
15th mo of treatment) were included in the LAL -AR -03 protocol, on the arm of intensified
induction. Those who do not reach the RC will be excluded from the study and will be treated
according to the protocol LAL-AR/03 , which will be incorporated receiving blocks
consolidation. All patients in CR consolidation treatment (1 and 2 ) followed reinducciones
maintenance (maintenance -1 ) to complete the first year of treatment and maintenance without
reinducciones (maintenance -2 ) to complete two years from the RC will be administered . If
after union persistent high levels of ER ( > 0.05 %) and this reappears later during
maintenance therapy the patient will be excluded from the study and will be treated according
to the protocol of high risk ( PETHEMA LAL-AR/03 ) . In case of persistent high levels of ER
patients after consolidation will consolidate blocks PETHEMA LAL-AR/03 protocol followed by
allogeneic HSCT . If the ER reappears during maintenance treatment the patient will receive
an allogeneic HSCT , Standby thereof, may be administered one or two blocks consolidation of
LAL -AR -03 protocol.
To allow time to better characterize the LLA and thus ensure proper inclusion of patients in
the study recommends administering a prephase with :
- Prednisone ( PDN) 60 mg/m2 po or iv through characterization of LAL with a maximum of 7
days.
intrathecal chemotherapy
- Methotrexate (MTX ) : 12 mg
- ARA - C: 30 mg
- Hydrocortisone 20 mg
The LAL meeting the inclusion criteria, the study may continue
Induction chemotherapy
- Vincristine (VCR ) 1.5 mg/m2 ( maximum dose 2 mg ) iv on days 1 and 8.
- daunorubicin (DNR ) 30 mg/m2 iv on days 1 and 8.
- Prednisone ( PDN ): 60 mg/m2 night , i.v. or p.o , 1-14 days
Study of bone marrow at day +14
- Less than 10% blasts ( by morphology) or hypocellular bone marrow
- Vincristine (VCR ) 1.5 mg/m2 ( maximum dose 2 mg) iv 15 and 22
- daunorubicin (DNR ) 30 mg/m2 i.v 15 and 22
- L -asparaginase ( L -ASA ) of E. coli ( Kidrolase ® ) : 10,000 IU/m2 , iv , 16-20 ,
23-27 .
- 1,000 mg/m2 cyclophosphamide , i.v. day 36
- Prednisone ( PDN) :
- 60 mg/m2 per day, i.v or p.o , days 15-27
- 30 mg/m2 per day, i.v or p.o , days 28-35
- Equal to or more than 10 % blasts ( by morphology)
- Step PETHEMA protocol LAL-AR/2003
Intrathecal chemotherapy
- Methotrexate (MTX ) 12 mg days 1 and 29
- ARA- C: 30 mg days 1 and 29
- Hydrocortisone 20 mg days 1 and 29
Evaluation at the end of induction (day 28 or when a finding hemoperiférica recovery)
- Patients RC : consolidation -1
- Patients without RC : excluded. Step PETHEMA LAL-AR/2003 protocol .
Study of the ER at the end of induction. Molecular response was considered if the ER is <
0.01 %. Although a molecular response is not achieved , the patient will remain in the
protocol if you have standard response at day 14 and is in CR at day 28 .
Consolidation treatment -1 These cycles include known cytostatics LAL activity against at
intermediate or high doses. This phase of treatment as possible to begin two weeks of the
administration of the last dose of cytostatic induction phase . The patient should have a WBC
count > 3x109 / L (granulocytes > 1.5 x 109 / L ) and platelets > 100x109 / L.
Mercaptopurine ( MP ) 50 mg/m2 , po, days 1-7 , 28-35 and 56-63 MTX : 3 g/m2 iv , in 24 hours
, day 1, 28 and 56 . For administration, and rescue treatment should be followed the rules
specified below .
VP -16 100 mg/m2 ( infusion 1 hour), 14-15 and 42-43 ARA- C 500 mg/m2 iv every 12 hours , 3
hours , 14-15 and 42-43 . Intrathecal Chemotherapy or Methotrexate ( MTX ) 12 mg on days 1,
28 and 56 or ARA- C: 30 mg days 1, 28 and 56 or Hydrocortisone 20 mg days 1, 28 and 56
Treatment consolidation-2/reinduction It consists of a cycle similar to the induction
chemotherapy . It will start if possible within one week of completion of the last dose of
mercaptopurine in the previous cycle (thus, from the 18th week of the start of treatment) .
Dexamethasone (DXM ) :
or 10 mg/m2 per day, p.o or i.v 1-14 days to 5 mg/m2 night , p.o or i.v., day 15 to 21 VCR
1.5 mg/m2 , i.v. , days 1, 8 and 15 DNR : 30 mg/m2 , i.v. , 1, 2 , 8 and 9 CFM and 600 mg/m2
day , i.v. , days 1 and 15 L -ASA E. coli ( Kidrolase ® ) : 10,000 IU/m2 i.m. or i.v., on
days 1-4 and 15-18 .
Intrathecal Chemotherapy or methotrexate (MTX ) 12 mg days 1 and 15 or ARA- C: 30 mg days 1
and 15 or Hydrocortisone 20 mg days 1 and 15
Evaluation of ER at the end of the consolidation A cytofluorometric study fee is mo If the ER
is > 0.05 % (tested on two separate occasions 15 days ) the patient will go to high-risk
protocol ( PETHEMA LAL-AR/2003 ) .
If ER < 0.05 % the patient continue the protocol.
Maintenance treatment with 1 reinducciones It will consist of continuous administration of
chemotherapy ( mercaptopurine and methotrexate ) with reinducciones up to a year from the
start of treatment. It lasts therefore between approximately 22 and 52 weeks of treatment.
Continuous Chemotherapy
- MP 50 mg/m2 per day, p.o
- MTX 20 mg/m2 per week , i.m. Reinducciones
- VCR 1.5 mg/m2 ( maximum dose 2 mg) , iv , day 1.
- PDN 60 mg/m2 night , i.v. or p.o , days 1-7
- L - ASA E. coli ( Kidrolase ® ) : 20,000 IU/m2 i.m. or i.v. , day 1.
- Intrathecal Chemotherapy Methotrexate (MTX ) 12 mg 1st ARA- C: 30 mg 1st Hydrocortisone
20 mg Day 1
During the week of administration of each cycle of chemotherapy reinduction continuous
suspended.
Evaluation after the fourth reinduction . Immunophenotypic study of a new bone marrow will be
made
- If ER is < 0.01 % , subsequent reinducciones are suspended and continues only with
continuous chemotherapy until week 52 , at which point it switches to maintenance -2.
- If ER between 0.05% and 0.01% , the reinducciones 5 was administered to 8
- If ER > 0.05 % (tested on two separate occasions 15 days ) the patient will go to
high-risk protocol ( PETHEMA LAL-AR/2003 ) .
Treatment Support 2 It consisitirá in continuous administration of chemotherapy (
mercaptopurine, and methotrexate ) to complete two years in continuous complete remission .
- MP 50 mg/m2 per day, p.o
- MTX 20 mg/m2 per week , i.m. Throughout the maintenance treatment should seek to retain
WBC counts between 2.5 and 5x109 / L and platelet counts above 120x109 / L. If these
lower limits should be reduced is decreased by 20 % doses of MP and MTX. If the numbers
of leukocytes exceed 5x109 / L will increase by 20 % the dose of MP (50 to 60 mg/m2 )
