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

NCT ID: NCT01490853

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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

Conditions

Chronic Myeloid Leukemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

CML and interpheron alpha

Adult Ph+CML pts in CCgR after IFN alpha.

Interpheron alpha

Intervention Type: DRUG

Long term outcom after interferon alpha discontinuation or not

Interventions

Interpheron alpha

Long term outcom after interferon alpha discontinuation or not

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Domenico Russo

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Domenico Russo

Role: STUDY_DIRECTOR

Università degli Studi di Brescia

Locations

Chair of hematology

Brescia, , Italy

Countries

Italy

Other Identifiers

CML0509

Identifier Type: -

Identifier Source: org_study_id