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

NCT01221376 | Unknown Phase 2

• 1 other identifier: CSTI571ABR23T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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+)

Outcome Measures

Primary Outcomes (1)

• Evaluate the complete cytogenetic response with continuous-use of Imatinib.

  Up to 12 months

Secondary Outcomes (1)

• Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.

  Up to 24 months

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

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

Also known as: Glivec, MI

Imatinib Mesylate

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Karnofsky and Lansky scale: ≥40.
• Life expectation \> 8 weeks.
• 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.
• CNS toxicity ≤ II
• Cardiac function: normal ejection fraction.
• Signed ICF by child legal responsible.

You may not qualify if:

• Patient receiving any other tyrosine kinase inhibitor (TKI).
• Pregnant patient or breastfeeding.
• Patient considered incapable to follow purposed treatment.
• Patients with molecular relapsed.
• 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.

Sponsors & Collaborators

• Renato Melaragno: lead

Study Sites (1)

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Alejandro M Arancibia, MD

  Casa de Saúde santa Marcelina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

BR (1)