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Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)


Phase 2
1 Year
18 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

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Trial Information

Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)


Inclusion Criteria:



1. Diagnose: therapy-naïve ALL, except for patients that performed Induction for ALL (33
days) exactly as this protocol and; documented Ph+, to be confirmed by conventional
cytogenetic - t(9;22) (q34;q11) or FISH and/or gene BCR-ABL presence by RT-PCR or
FISH.

2. Female patients of childbearing age, should have pregnancy test (blood βhCG)
performed before treatment initiation. Effective contraception must be used during
treatment. Pregnant women won't be included.

3. Life expectation > 8 weeks.

4. Medications: antineoplastic treatment-naïve, including corticotherapy, except for
patients that performed Induction for ALL (33 days) exactly as this protocol.

5. Signed ICF by child legal responsible.

6. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70
ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP/TGO < 10 x ULN and
albumin > 2 g/dl.

Exclusion Criteria:

1. Any inclusion criteria missing.

2. Pregnant patient or breastfeeding.

3. Patient considered incapable to follow purposed treatment.

4. Subject with infectious process, in activity, grade IV.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+.

Outcome Description:

Cytogenetic and molecular response will be evaluate at the end of Induction I (D33), before each consolidation block (HR 1, 2 and 3), before re-induction, before maintenanceand at the end of therapy.

Outcome Time Frame:

Up to 24 months.

Safety Issue:

No

Authority:

Brazil: Ethics Committee

Study ID:

CSTI571ABR22T

NCT ID:

NCT01222013

Start Date:

Completion Date:

Related Keywords:

  • Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

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