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:
Renato Melaragno
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations 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:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic |
Chromosome Aberrations Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013