Chronic Myeloid Leukemia (CML)Phase 1NCT01066468
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
A Phase 1 study testing Gleevec/Glivec in people with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL), run by Novartis Pharmaceuticals at 1 site in Russia.
Trial summary
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL), Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
- What is being tested?
- Gleevec/Glivec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2010to May 2011
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be 1 to less than 4 years of age at study entry
- Written informed consent must be signed by the patient's parent or legal guardian.
- Patients must have the diagnosis of CML or Ph+ ALL
- Lansky score must be ≥ 50 (Table7-2)
- Patient must have adequate end organ function as defined by
- Total bilirubin < 1.5 x ULN
- SGPT (ALT) and SGOT (AST) < 2.5 x UNL
- Creatinine < 1.5 x ULN
Who cannot join
- Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
- Patients who previously received radiotherapy to ≥ 25% of the bone marrow, with the exception of patients who received total body radiation as part of a preparatory regimen for hematopoetic stem cell transplant (HSCT)
- Patients receiving antibacterial and antipyretic medication to treat active infection
- Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
- Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) of Glivec/Gleevec® (Imatinib Mesylate) in Pediatric (Age Range 1 to Less Than 4 Years) Patients With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) or Other Glivec/ Gleevec® Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens
- Conditions
- Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL), Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
- Being tested
- Gleevec/Glivec
- Keywords
- Chronic myeloid leukemia, CML, Philadelphia chromosome positive, acute lymphoblastic leukemia, PhGlivec,, Gleevec,, hypereosinophilic syndrome,, HES,, chronic eosinophilic leukemia,, CEL,, myelodysplastic syndrome,, MDS,, myeloproliferative disease,, MPD+ ALL
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pdgfra-Associated Chronic Eosinophilic Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gleevec/GlivecDrug
Also called STI571
| Study group | Role | What they receive |
|---|---|---|
| Gleevec/Glivec | Experimental | Not described Receives: Drug: Gleevec/Glivec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Pharmacokinetic data o (CL/F (clearance) o V/F (Volume of distribution) o Tmax o Physiologically based pharmacokinetic (PBPK) parameters (plasma protein binding and α-1 acid glycoprotein concentration)
Measured: 2 PK sample collection within 21 days
Secondary outcomes (1)
safety and tolerability of imatinib during the study period
Measured: study period of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066468
- Sponsor's protocol ID
- CSTI571A2110
- Other IDs
- 2010-018418-53
- Status last verified
- Mar 2012
- First submitted
- 9 Feb 2010
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No