LeukemiaNCT01395628
Cell Samples From Patients With Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- in vitro sensitivity-directed chemotherapy, cell proliferation assay and fluorescence activated cell sorting
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to May 2016
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with myeloid disease.
DISEASE CHARACTERISTICS:
- Samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes:
- Chronic phase chronic myeloid leukemia (CML), to complement initial studies in the K562 CML cell line
- Acute promyelocytic leukemia (APL), to complement initial studies in the NB4 APL cell line
- Acute myeloid leukemia (AML) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric AML and is associated with good prognosis
- AML expressing 5q- or monosomy 7, associated with a poor prognosis
- AML expressing the fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), associated with a poor prognosis
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Xenotransplantation of Primary Leukemia Samples Into Zebrafish
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial is studying samples from patients with leukemia.
Read the detailed description
OBJECTIVES:
- Demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo.
- Confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo.
- Evaluate the effect of novel anticancer drugs and/or their combinations on individual samples.
OUTLINE: This is a multicenter study.
Cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. After 1 hour of recovery at 28° C, embryos are maintained at 38° C and screened for fluorescence at the injection site. Within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. Proliferation of leukemia cells are monitored by live-cell microscopy. Cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. Leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.
- Conditions
- Leukemia
- Being tested
- in vitro sensitivity-directed chemotherapy, cell proliferation assay, fluorescence activated cell sorting, laboratory biomarker analysis, microscopy
- Keywords
- chronic phase chronic myelogenous leukemia, childhood acute promyelocytic leukemia (M3), childhood acute myeloid leukemia/other myeloid malignancies, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with del(5q), adult acute promyelocytic leukemia (M3)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro sensitivity-directed chemotherapyDrug
cell proliferation assayOther
fluorescence activated cell sortingOther
laboratory biomarker analysisOther
microscopyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo
In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells
Effects of novel anticancer drugs and/or their combinations on individual samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2016
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 Children's Oncology GroupThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason N. Berman, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395628
- Sponsor's protocol ID
- AAML11B13
- Other IDs
- COG-AAML11B13, AAML11B13, NCI-2011-02863
- Status last verified
- May 2016
- First submitted
- 14 Jul 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenotransplantation of Primary Leukemia Samples Into Zebrafish
- ClinicalTrials.gov ID
- NCT01395628
- Acronym / sponsor ID
- AAML11B13
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, childhood acute promyelocytic leukemia (M3), childhood acute myeloid leukemia/other myeloid malignancies, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with del(5q), adult acute promyelocytic leukemia (M3)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- First posted
- 15 Jul 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.
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial is studying samples from patients with leukemia.
Detailed description
OBJECTIVES:
- Demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo.
- Confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo.
- Evaluate the effect of novel anticancer drugs and/or their combinations on individual samples.
OUTLINE: This is a multicenter study.
Cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. After 1 hour of recovery at 28° C, embryos are maintained at 38° C and screened for fluorescence at the injection site. Within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. Proliferation of leukemia cells are monitored by live-cell microscopy. Cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. Leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with myeloid disease.
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 |
|---|---|---|
| in vitro sensitivity-directed chemotherapy | Drug | – |
| cell proliferation assay | Other | – |
| fluorescence activated cell sorting | Other | – |
| laboratory biomarker analysis | Other | – |
| microscopy | Other | – |
Primary outcome
Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo
In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells
Effects of novel anticancer drugs and/or their combinations on individual samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
Related trials for Leukemia
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
Active, not recruitingObservational study
Observatory of Prolymphocytic Leukemia T
Prolymphocytic Leukemia, T-cell Leukemia
RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
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.
Jason N. Berman, MD principal investigator
IWK Health Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo. The study lists 3 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 19 May 2016.