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

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ClinicalTrials.gov Identifier: NCT01490853
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : November 13, 2018
Sponsor:
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia

Tracking Information
First Submitted Date December 1, 2011
First Posted Date December 13, 2011
Last Update Posted Date November 13, 2018
Study Start Date October 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2011)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy
Official Title Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult (>18 years old) patients with CP Ph+/BCR-ABL CML and with CCgR after therapy including IFN alpha.
Condition Chronic Myeloid Leukemia
Intervention Drug: Interpheron alpha
Long term outcom after interferon alpha discontinuation or not
Study Groups/Cohorts CML and interpheron alpha
Adult Ph+CML pts in CCgR after IFN alpha.
Intervention: Drug: Interpheron alpha
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2011)
116
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01490853
Other Study ID Numbers CML0509
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Domenico Russo, Università degli Studi di Brescia
Study Sponsor Università degli Studi di Brescia
Collaborators Not Provided
Investigators
Study Director: Domenico Russo Università degli Studi di Brescia
PRS Account Università degli Studi di Brescia
Verification Date November 2018