Leukemia, Chronic LymphaticNCT02020109
Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia
An observational study of Leukemia, Chronic Lymphatic, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Chronic Lymphatic
- What is being tested?
- splenic irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Jan 2017
- 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 with chronic lymphatic leukaemia (CLL).
Who may be able to join
- patients with chronic lymphatic leukaemia.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)
Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).
Read the detailed description
The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death
- Conditions
- Leukemia, Chronic Lymphatic
- Being tested
- splenic irradiation
- 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.
splenic irradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Lymphatic Leukemia | Patients with Chronic Lymphatic Leukemia treated with splenic irradiation Receives: Radiation: splenic irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and haematological response
Clinical and haematological response measured by number of leucocytes and thrombocytes during and after irradiation. Hemoglobin and size of spleen during and after irradiation in the time period 2000 tot 2013
Measured: 13 years
Secondary outcomes (3)
Progression of chronic Lymphatic leukaemia
Progression of chronic Lymphatic leukaemia after irradiation in the time period 2000 tot 2013
Measured: 13 years
Death
Patients will be followed from the time of splenic irradiation to death in the time period of 2000 tot 2013
Measured: 13 years
Toxicity of splenic irradiation
Toxicity of splenic irradiation during and after irradiation measured by evaluating clinical toxicity based on the CTCAE version 3.0 during and after irradiation (2000 to 2013)
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Logistics and financial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Chronic LymphaticStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Borger, dr., Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020109
- Sponsor's protocol ID
- 13-11-05/06-extern-6295
- Status last verified
- Apr 2018
- First submitted
- 12 Dec 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT02020109
- Acronym / sponsor ID
- 13-11-05/06-extern-6295
- Conditions
- Leukemia, Chronic Lymphatic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistics and financial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Dec 2013 (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.
Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).
Detailed description
The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Lymphatic Leukemia | – | Radiation: splenic irradiationPatients with Chronic Lymphatic Leukemia treated with splenic irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic lymphatic leukaemia (CLL).
Key inclusion criteria (1 listed)
- patients with chronic lymphatic leukaemia.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| splenic irradiation | Radiation | Patients with Chronic Lymphatic Leukemia |
Primary outcome
Clinical and haematological response
Time frame: 13 years
Clinical and haematological response measured by number of leucocytes and thrombocytes during and after irradiation. Hemoglobin and size of spleen during and after irradiation in the time period 2000 tot 2013
3 secondary outcomes
Progression of chronic Lymphatic leukaemia
Time frame: 13 years
Death
Time frame: 13 years
Toxicity of splenic irradiation
Time frame: 13 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Leukemia, Chronic Lymphatic
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
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.
Jacques Borger, dr. principal investigator
Maastro Clinic, The Netherlands
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 Leukemia, Chronic Lymphatic, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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: withdrawn, as of the sponsor's last update on 5 Apr 2018. 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 Netherlands. 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 withdrawn before enrolling participants, so there are no results.
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?
Clinical and haematological response (time frame: 13 years). 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 5 Apr 2018.