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Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020109
Recruitment Status : Withdrawn (Logistics and financial)
First Posted : December 24, 2013
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).

Condition or disease Intervention/treatment
Leukemia, Chronic Lymphatic Radiation: splenic irradiation

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)
Study Start Date : September 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Chronic Lymphatic Leukemia
Patients with Chronic Lymphatic Leukemia treated with splenic irradiation
Radiation: splenic irradiation



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression of chronic Lymphatic leukaemia [ Time Frame: 13 years ]
    Progression of chronic Lymphatic leukaemia after irradiation in the time period 2000 tot 2013

  2. Death [ Time Frame: 13 years ]
    Patients will be followed from the time of splenic irradiation to death in the time period of 2000 tot 2013

  3. Toxicity of splenic irradiation [ Time Frame: 13 years ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic lymphatic leukaemia (CLL).
Criteria

Inclusion Criteria:

  • patients with chronic lymphatic leukaemia.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020109


Locations
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Netherlands
Maastro Clinic
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
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Principal Investigator: Jacques Borger, dr. Maastro Clinic, The Netherlands
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02020109    
Other Study ID Numbers: 13-11-05/06-extern-6295
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell