LeukemiaNCT00631059
Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients
A study testing Hem(A)+ Technology in people with Leukemia, run by University of California, Irvine at 1 site in United States.
Trial summary
The objective of this protocol is to collect leukemia cell specimens from adults (18 years of age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Hem(A)+ Technology
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly Diagnosed Subjects
- The subject is male or female, aged 18 years of age or older
- The subject has a diagnosis of acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML); the subject must have a pathology-confirmed diagnosis
- The subject must have a pathology-confirmed diagnosis
- Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having >25% blasts in the bone marrow and/or peripheral blood
- The subject has not received any chemotherapy or treatment for their acute leukemia prior to the initial study visit
Show all 18Show fewer
- The subject is able and willing to provide written informed consent
- The subject is able to understand the study and cooperate with all study instructions
- Relapsed Subjects
- The subject is male or female, aged 18 years of age or older
- The subject has a diagnosis of relapsed acute lymphocytic leukemia (ALL) or relapsed acute myelogenous leukemia (AML)
- The subject must have a pathology-confirmed diagnosis
- Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having ≥ 25% blasts in the bone marrow and/or peripheral blood
- The subject has received one or more of the pre-identified chemotherapeutic agents for treatment of their initial acute leukemia diagnosis
- The subject has not received any systemic chemotherapy or treatment for their relapsed acute leukemia
- Receipt of intrathecal chemotherapy will be permissible
- The subject is able and willing to provide written informed consent
- The subject is able to understand the study and cooperate with all study instructions
Who cannot join
- The subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
- The subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
- Subjects under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
The objective of this protocol is to collect leukemia cell specimens from adults (18 years of age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse. These specimens, in conjunction with a de-identified data set, will be utilized prospectively to determine potential chemotherapy resistance in this patient population.
The specific aims of this study are as follows:
Read more
To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology
To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay to determine the following:
Predict responders and non-responders to common chemotherapeutic agents Track treatment results and comparison to prediction results from the assay Identify optimal chemotherapy doses for each patient Identify the most efficacious pharmaceutical agent combinations
- Conditions
- Leukemia
- Being tested
- Hem(A)+ Technology
- Keywords
- Hitachi, Leukemia, Relapse, Chemotherapy Resistance
- Medical subject headings
- Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hem(A)+ TechnologyOther
The purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse
Measured: No Projected Closing Date
Secondary outcomes (2)
To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology
Measured: No Projected Closing Date
To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay
Measured: No Projected Closing Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2008
- Study completionJun 2010
Why it stopped: Haluted due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Investigators
- Leonard S. Sender, MD, Principal investigator, UCI Department of Medicine -- Hematology/Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631059
- Sponsor's protocol ID
- UCI 07-46
- Other IDs
- HS# 2007-6051
- Status last verified
- Oct 2010
- First submitted
- 27 Feb 2008
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients
- ClinicalTrials.gov ID
- NCT00631059
- Acronym / sponsor ID
- UCI 07-46
- Conditions
- Leukemia
- Keywords
- Hitachi, Leukemia, Relapse, Chemotherapy Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Haluted due to slow accrual
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Mar 2008
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Mar 2008 (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 objective of this protocol is to collect leukemia cell specimens from adults (18 years of age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse. These specimens, in conjunction with a de-identified data set, will be utilized prospectively to determine potential chemotherapy resistance in this patient population.
The specific aims of this study are as follows:
To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology
To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay to determine the following:
Predict responders and non-responders to common chemotherapeutic agents Track treatment results and comparison to prediction results from the assay Identify optimal chemotherapy doses for each patient Identify the most efficacious pharmaceutical agent combinations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Newly Diagnosed Subjects
- The subject is male or female, aged 18 years of age or older
- The subject has a diagnosis of acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML); the subject must have a pathology-confirmed diagnosis
- The subject must have a pathology-confirmed diagnosis
- Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having >25% blasts in the bone marrow and/or peripheral blood
Key exclusion criteria (3 listed)
- The subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
- The subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
- Subjects under the age of 18
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 |
|---|---|---|
| Hem(A)+ TechnologyThe purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology. | Other | – |
Primary outcome
To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse
Time frame: No Projected Closing Date
2 secondary outcomes
To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology
Time frame: No Projected Closing Date
To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay
Time frame: No Projected Closing Date
Results and safety
The study was stopped early (reason given: Haluted due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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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.
Leonard S. Sender, MD principal investigator
UCI Department of Medicine -- Hematology/Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hem(A)+ Technology in people with Leukemia, run by University of California, Irvine at 1 site in United States.
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 18 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Oct 2010. 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 United States. 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?
The study was stopped early (reason given: Haluted due to slow accrual). 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 collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse (time frame: No Projected Closing Date). 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 13 Oct 2010.