Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

Leukemia, Chronic Lymphatic Clinical Trial

Official title:

Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02020109
• Other study ID #: 13-11-05/06-extern-6295
• Status: Withdrawn
• First received: December 12, 2013
• Last updated: April 4, 2018
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2018
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with chronic lymphatic leukaemia.

Exclusion Criteria:

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Chronic Lymphatic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Radiation:
• splenic irradiation

Locations

Country	Name	City	State
Netherlands	Maastro Clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

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