Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)Phase 2NCT01221376
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
A Phase 2 study testing Imatinib Mesylate in people with Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+), run by Renato Melaragno at 1 site in Brazil.
Trial 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+. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)
- What is being tested?
- Imatinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
- Being tested
- Imatinib Mesylate
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called Glivec, MI
Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate | Experimental | Not described Receives: Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the complete cytogenetic response with continuous-use of Imatinib.
Measured: 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+.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
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) With Philadelphia Chromosome-positive (Ph+)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renato Melaragno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renato Melaragno, Hospital Santa Marcelina
- Investigators
- Alejandro M Arancibia, MD, Study chair, Casa de Saúde santa Marcelina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221376
- Sponsor's protocol ID
- CSTI571ABR23T
- Status last verified
- Mar 2013
- First submitted
- 14 Oct 2010
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
- ClinicalTrials.gov ID
- NCT01221376
- Acronym / sponsor ID
- CSTI571ABR23T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Renato MelaragnoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate | Experimental | Drug: Imatinib Mesylate |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- Patient receiving any other tyrosine kinase inhibitor (TKI).
- Pregnant patient or breastfeeding.
- Patient considered incapable to follow purposed treatment.
- Patients with molecular relapsed.
- Medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib MesylateAlso: Glivec, MIPatient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months. | Drug | Imatinib Mesylate |
Primary outcome
Evaluate the complete cytogenetic response with continuous-use of Imatinib.
Time frame: Up to 12 months
1 secondary outcome
Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro M Arancibia, MD study chair
Casa de Saúde santa Marcelina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib Mesylate in people with Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+), run by Renato Melaragno at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the complete cytogenetic response with continuous-use of Imatinib. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.