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

NCT ID: NCT01222013

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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+.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imatinib Mesylate

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.

Interventions

Imatinib Mesylate

patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.

Intervention Type: DRUG

Other Intervention Names

Glivec, MI

Eligibility Criteria

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.

2. Pregnant patient or breastfeeding.

3. Patient considered incapable to follow purposed treatment.

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renato Melaragno

OTHER

Sponsor Role: lead

Responsible Party

Renato Melaragno

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

CSTI571ABR22T

Identifier Type: -

Identifier Source: org_study_id