Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives

This is an observational study aimed at updating the overall survival (OS), the progression free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing the clinical and biological features of this selected cohort of patients with persisting CCgR after treatment with IFN.

Study design This study is an observational retrospective multicenter study.

Assessment and Follow-up Patients' demographic data and retrospective collection of CML cytogenetic and molecular data will be reported in the "Assessment and Follow-up FORM".

In this FORM the events related to therapy, disease and survival will also be reported.

Duration of the study:

The recruitment period is estimated in approximately 2 years.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università degli Studi di Brescia
• Treatments: Interferons

Criteria

Inclusion criteria

• Age > 18 years

• Ph+/BCR-ABL+ CML in CP

• Treatment with IFN alpha alone or in combination ( i.e HU, Ara-C, YNK01, ASCT ), either within or outside national Study Protocols.

• Complete cytogenetic response (CCgR) (0% Ph+ cells)

• Written informed consent prior to any study procedures being performed.

Exclusion Criteria:

• Patients with Ph+ CML in accelerated/blastic phase (AP/BP)

• No treatment with Interferon-alpha

• No written informed consent prior to any study procedures being performed.