NCT02020109

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

December 12, 2013

Last Update Submit

April 4, 2018

Conditions

Leukemia, Chronic Lymphatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Progression of chronic Lymphatic leukaemia

    13 years

  • Death

    13 years

  • Toxicity of splenic irradiation

    13 years

Study Arms (1)

Patients with Chronic Lymphatic Leukemia

Patients with Chronic Lymphatic Leukemia treated with splenic irradiation

Radiation: splenic irradiation

Interventions

splenic irradiationRADIATION
Patients with Chronic Lymphatic Leukemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic lymphatic leukaemia (CLL).

You may qualify if:

  • patients with chronic lymphatic leukaemia.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastro Clinic

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacques Borger, dr.

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 24, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

NL(1)