Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

NCT ID: NCT01221376

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.

Conditions

Chronic Myeloid Leukemia (CML) With 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 Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.

Interventions

Imatinib Mesylate

Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.

Intervention Type: DRUG

Other Intervention Names

Glivec, MI

Eligibility Criteria

Inclusion Criteria

1. Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase [LAP]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.

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

3. Karnofsky and Lansky scale: ≥40.

4. Life expectation > 8 weeks.

5. 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 < 3 x ULN and albumin > 2 g/dl.

6. CNS toxicity ≤ II

7. Cardiac function: normal ejection fraction.

8. Signed ICF by child legal responsible.

Exclusion Criteria

1. Patient receiving any other tyrosine kinase inhibitor (TKI).

2. Pregnant patient or breastfeeding.

3. Patient considered incapable to follow purposed treatment.

4. Patients with molecular relapsed.

5. Medications:

• Colony stimulating: it cannot be administered at least 1 week before treatment.
• Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
• Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets < 50000.
• INF-Α 48h before D1.
• Hydroxyurea 24h before D1.
• ARA-C doses >100 mg/m2 for 5-7 days, 14 days before D1.
• Anthracyclines, Mitoxantrone or Etoposide 21 days before D1.
• Any other chemotherapeutic agent 28 days before D1.
• Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.

• 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

Principal Investigators

Alejandro M Arancibia, MD

Role: STUDY_CHAIR

Casa de Saúde santa Marcelina

Locations

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CSTI571ABR23T

Identifier Type: -

Identifier Source: org_study_id