Status:

COMPLETED

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

Lead Sponsor:

Università degli Studi di Brescia

Conditions:

Chronic Myeloid Leukemia

Eligibility:

All Genders

18+ years

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 (CCg...

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 m...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2009

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2014

    Estimated Enrollment :

    116 Patients enrolled

    Trial Details

    Trial ID

    NCT01490853

    Start Date

    October 1 2009

    End Date

    December 1 2014

    Last Update

    November 13 2018

    Active Locations (1)

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    Chair of hematology

    Brescia, Italy, 25123