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NCT Number: NCT01490853

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chair of hematology

Brescia, 25123, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interpheron alpha

Drug

Long term outcom after interferon alpha discontinuation or not

Primary outcomes

  1. Progression Free Survival

    Time frame: From date of enrollment until the date of first documented progression, assessed up to 240 months

    One primary outcome measure is the PFS of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.

  2. Duration of Complete Cytogenetic Response (CCgR)

    Time frame: From date of enrollment until the date of first documented loss of CCgR, assessed up to 240 months

    One primary outcome measure is the duration of CCgR of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.

  3. Overall Survival

    Time frame: From date of enrollment until the date of first documented death from any cause, assessed up to 240 months

    OS will be calculated from the date of diagnosis until date of death (whatever the cause). Patients still alive will be censored at the moment of last follow-up.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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