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

Renato Melaragno

Status and phase: Suspended; Phase 2

Conditions: Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Treatments: Drug: Imatinib Mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT01222013

CSTI571ABR22T

Details and patient eligibility

About

The purpose of this study is to 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+.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Imatinib Mesylate

Experimental group

Treatment:

Drug: Imatinib Mesylate