Acute Lymphoblastic Leukemia.NCT01307241
RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML
An observational study of Acute Lymphoblastic Leukemia. and Acute Myeloblastic Leukemia, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical \& molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia., Acute Myeloblastic Leukemia
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2010to Dec 2015
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute lymphoblastic leukemia
Who may be able to join
- Age: older than 15 years.
- Male, female.
- Normal renal \& liver functions.
- Without previous treatment.
- Candidate to be treated with hyperCVAD Schema (ALL patients).
- Candidate to receive induction remission with cytarabine (AML patients)
Who cannot join
- Patients not candidate to receive methotrexate or cytarabine.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080
About this study
Official title: Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.
Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical \& molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders \& non-responders patients. Uni- \& multivariate analysis will be done to evaluate factors influencing on response and survival.
- Keywords
- Acute lymphoblastic leukemia, prognostic factor, pharmacogenetics.
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one cohort | Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical response
To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response \& DFS in relation with hENT1 \& dCK expression levels in AML patients.
Measured: December 2012
Clinical responses in relation with SNP's or gene expression
Measured: clinical response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia.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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR. MYRNA CANDELARIA, National Institute of Cancerología
- Investigators
- myrna candelaria, md, Principal investigator, Instituto Nacional de Cancerología Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307241
- Sponsor's protocol ID
- 010/020/ICI
- Status last verified
- Nov 2013
- First submitted
- 28 Feb 2011
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT01307241
- Acronym / sponsor ID
- 010/020/ICI
- Keywords
- Acute lymphoblastic leukemia, prognostic factor, pharmacogenetics.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Mar 2011 (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.
Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical \& molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders \& non-responders patients. Uni- \& multivariate analysis will be done to evaluate factors influencing on response and survival.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one cohort | – | –Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute lymphoblastic leukemia
Key inclusion criteria (6 listed)
- Age: older than 15 years.
- Male, female.
- Normal renal \& liver functions.
- Without previous treatment.
- Candidate to be treated with hyperCVAD Schema (ALL patients).
Key exclusion criteria (1 listed)
- Patients not candidate to receive methotrexate or cytarabine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate clinical response
Time frame: December 2012
To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response \& DFS in relation with hENT1 \& dCK expression levels in AML patients.
Clinical responses in relation with SNP's or gene expression
Time frame: clinical response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
myrna candelaria, md principal investigator
Instituto Nacional de Cancerología Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia. and Acute Myeloblastic Leukemia, run by National Institute of Cancerología at 1 site in Mexico.
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 6 inclusion and 1 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 15 Nov 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 Mexico. 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.
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?
To evaluate clinical response (time frame: December 2012). The study lists 2 primary outcomes in all. 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 15 Nov 2013.