Chronic Lymphocytic LeukemiaNCT00889031
Protocol to Obtain Blood Samples for Leukemia Research
An observational study of Chronic Lymphocytic Leukemia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 9 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center
Who may be able to join
- Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC.
Who cannot join
- Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL).
Read the detailed description
The blood sample will be used in the laboratory to perform studies focusing on Chronic Lymphocytic Leukemia (CLL).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- No Intervention
- Keywords
- CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Patients with Chronic Lymphocytic Leukemia (CLL)
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency with which CLL cells incubated ex vivo with vincristine undergo rapid interphase apoptosis.
Measured: 2 Years
Secondary outcomes (1)
To determine whether suppression or inhibition of BCL2 family members can acutely sensitize CLL cells to vincristine.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center
- Investigators
- Christopher H Lowrey, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889031
- Sponsor's protocol ID
- D0905
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2009
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stadheim TA, Xiao H, Eastman A. Inhibition of extracellular signal-regulated kinase (ERK) mediates cell cycle phase independent apoptosis in vinblastine-treated ML-1 cells. Cancer Res. 2001 Feb 15;61(4):1533-40.
PubMed 11245462Vilpo JA, Koski T, Vilpo LM. Selective toxicity of vincristine against chronic lymphocytic leukemia cells in vitro. Eur J Haematol. 2000 Dec;65(6):370-8. doi: 10.1034/j.1600-0609.2000.065006370.x.
PubMed 11168494Kivekas I, Vilpo L, Vilpo J. Relationships of in vitro sensitivities tested with nine drugs and two types of irradiation in chronic lymphocytic leukemia. Leuk Res. 2002 Nov;26(11):1035-41. doi: 10.1016/s0145-2126(02)00050-4.
PubMed 12363473
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Obtain Blood Samples for Leukemia Research
- ClinicalTrials.gov ID
- NCT00889031
- Acronym / sponsor ID
- D0905
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 28 Apr 2009 (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 collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL).
Detailed description
The blood sample will be used in the laboratory to perform studies focusing on Chronic Lymphocytic Leukemia (CLL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | Other: No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center
Key inclusion criteria (1 listed)
- Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC.
Key exclusion criteria (1 listed)
- Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.
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 |
|---|---|---|
| No InterventionPatients with Chronic Lymphocytic Leukemia (CLL) | Other | No Treatment |
Primary outcome
To determine the frequency with which CLL cells incubated ex vivo with vincristine undergo rapid interphase apoptosis.
Time frame: 2 Years
1 secondary outcome
To determine whether suppression or inhibition of BCL2 family members can acutely sensitize CLL cells to vincristine.
Time frame: 2 Years
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 7 Apr 2020.
- Background: PubMed 11245462Stadheim TA, Xiao H, Eastman A. Inhibition of extracellular signal-regulated kinase (ERK) mediates cell cycle phase independent apoptosis in vinblastine-treated ML-1 cells. Cancer Res. 2001 Feb 15;61(4):1533-40.
- Background: PubMed 11168494Vilpo JA, Koski T, Vilpo LM. Selective toxicity of vincristine against chronic lymphocytic leukemia cells in vitro. Eur J Haematol. 2000 Dec;65(6):370-8. doi: 10.1034/j.1600-0609.2000.065006370.x.
- Background: PubMed 12363473Kivekas I, Vilpo L, Vilpo J. Relationships of in vitro sensitivities tested with nine drugs and two types of irradiation in chronic lymphocytic leukemia. Leuk Res. 2002 Nov;26(11):1035-41. doi: 10.1016/s0145-2126(02)00050-4.
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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.
Christopher H Lowrey, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 Chronic Lymphocytic Leukemia, run by Dartmouth-Hitchcock Medical Center 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 1 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 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?
To determine the frequency with which CLL cells incubated ex vivo with vincristine undergo rapid interphase apoptosis. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889031, which also lists 3 linked publications.
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 7 Apr 2020.