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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Renato Melaragno, Hospital Santa Marcelina
ClinicalTrials.gov Identifier:
NCT01221376
First received: October 14, 2010
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)
Drug: Imatinib Mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Resource links provided by NLM:


Further study details as provided by Hospital Santa Marcelina:

Primary Outcome Measures:
  • Evaluate the complete cytogenetic response with continuous-use of Imatinib. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+. [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate Drug: Imatinib Mesylate
Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.
Other Name: Glivec, MI

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221376

Locations
Brazil
Hospital Santa Marcelina
Sao Paulo, SP, Brazil, 08270-070
Sponsors and Collaborators
Renato Melaragno
Investigators
Study Chair: Alejandro M Arancibia, MD Casa de Saúde Santa Marcelina
  More Information

No publications provided

Responsible Party: Renato Melaragno, MD, Hospital Santa Marcelina
ClinicalTrials.gov Identifier: NCT01221376     History of Changes
Other Study ID Numbers: CSTI571ABR23T
Study First Received: October 14, 2010
Last Updated: March 25, 2013
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Abnormal Karyotype
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Philadelphia Chromosome
Bone Marrow Diseases
Chromosome Aberrations
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014