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LAL-BR/2001: Study Treatment to Low Risk ALL


Phase 4
N/A
15 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

LAL-BR/2001: Study Treatment to Low Risk ALL


REMISION INDUCTION

Systemic chemotherapy:

Prednisolone (PDN):

- 60 mg/m2 day, i.v. or p.o., days 1 to 27

- 30 mg/m2 day, i.v. or p.o., days 28 to 35

Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2,
i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16
to 18 and 23 to 25.

Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.

Intracranial chemotherapy

Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)

- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63

- MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.

- VP-16: 150 mg/m2 i.v., days 14-15 and 42-43

- ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43

- Intrathecal treatment, days 1, 28 and 56.

REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)

Dexamethasone (DXM):

- 6 mg/m2 day, p.o., days 1-21

- 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30
mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22
and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days
35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C:
1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.

MAINTENANCE TREATMENT (M-1)

Continuous treatment

- MP 50 mg/m2/day, p.o.

- MTX 20 mg/m2/week, i.m.

Reinductions

- VCR: 1,5 mg/m2 i.v., day 1.

- PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7

- L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.

- Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week
of administration cycle, continuous chemotherapy should be suspended.

Intrathecal treatment: At the start of any reinduction cycle

MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)

- MP 50 mg/m2/day, p.o.

- MTX 20 mg/m2/week, i.m.

- Intrathecal treatment, weeks 54 and 108

At the end of treatment should be done the study of MRD (flux cytometry)


Inclusion Criteria:



- Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously

Exclusion Criteria:

- Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14],
t[2;8], t[8;22])

- Mixed forms of ALL

- Acute Leukemia no differentiate

- Patients with coronary disorders, valvular or hypertensive cardiopathy

- Patients with chronic liver disorders

- Chronic pulmonary disorders

- Renal insufficiency

- Neurologic disfunctions

- ECOG 3 and 4

- No signed consent form

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ribera Josep Mª, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Ministry of Health

Study ID:

LAL-BR/2001

NCT ID:

NCT00526175

Start Date:

June 2001

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Minimal Residual Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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