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

Università degli Studi di Brescia

Status

Completed

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Interpheron alpha

Study type

Observational

Funder types

Other

Identifiers

NCT01490853

CML0509

Details and patient eligibility

About

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.

Full description

Study rational

IFN, either alone or in combination with AC, prolonged survival of Ph+ CML patients, in early chronic phase, mainly in those patients achieving the CCgR
CCgR became the surrogate marker for survival duration and the main target of IFN therapy
CCgR were rare events accounting for less than 10% of the cytogenetic responsive patients
These cases can be considered as a fascinating elite of patients who have the highest sensitivity to IFN and are the most likely candidates for prolonged survival and possibly cure
From 1986 to 2001, more than 1200 CML patients either enrolled in different national trials or referred in single Institutions have been treated frontline with IFN based therapy
In 2001, data on 317 CCgRs were reported by the EICML group
They included 214 cases treated with IFN alone collected from the database of 9 national study groups in Austria, Belgium, Netherlands, France, Germany, Italy, Spain, Sweden and United Kingdom and 103 cases treated with IFN alone collected from single Institutions in Italy, France, and United Kingdom.
The study did not include the patients achieving CCgR with IFN + LDAC
The contribution of Italy was of 119 cases: 59 from national studies and 60 from single Institutions
The follow-up of these patients is stopped at 2000 and from 2000 thereafter almost CML patients were treated with IM
We don't know if the patients who had achieved a CCgR with IFN based therapy continued or discontinued IFN, or crossed to IM therapy
We don't know if they maintained a CCgR with or without therapy
We don't know if the patients who achieved a CCgR with IFN and crossed to IM had the same cytogenetic and molecular response, PFS and OS as the majority of the patients unresponsive to IFN who were treated with IM
We don't know the clinical and biological features of these selected cohort of patients

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: