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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01490853
First received: December 1, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Chronic Myeloid Leukemia
Drug: Interpheron alpha

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: From date of enrollment until the date of first documented progression, assessed up to 240 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 116
Study Start Date: October 2009
Estimated Study Completion Date: April 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CML and interpheron alpha
Adult Ph+CML pts in CCgR after IFN alpha.
Drug: Interpheron alpha
Long term outcom after interferon alpha discontinuation or not

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490853

Locations
Italy
Chair of hematology
Brescia, Italy, 25123
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
Study Director: Domenico Russo Università degli Studi di Brescia
  More Information

No publications provided

Responsible Party: Domenico Russo, Director, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01490853     History of Changes
Other Study ID Numbers: CML0509
Study First Received: December 1, 2011
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Brescia:
Ph pos CML
Philadelphia positive Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 21, 2014