Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02020109

Enrollment

Registered

2013-12-24

Start date

2013-09-30

Completion date

2017-01-31

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Chronic Lymphatic

Brief summary

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

Interventions

RADIATIONsplenic irradiation

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with chronic lymphatic leukaemia.

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Clinical and haematological response	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

Measure	Time frame	Description
Progression of chronic Lymphatic leukaemia	13 years	Progression of chronic Lymphatic leukaemia after irradiation in the time period 2000 tot 2013
Death	13 years	Patients will be followed from the time of splenic irradiation to death in the time period of 2000 tot 2013
Toxicity of splenic irradiation	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)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026