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

NCT01490853 | Completed DMC

• 1 other identifier: CML0509
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Keywords

Ph pos CML; Philadelphia positive Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Progression Free Survival

  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.

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

• Duration of Complete Cytogenetic Response (CCgR)

  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.

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

• Overall Survival

  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.

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

Study Arms (1)

CML and interpheron alpha

Adult Ph+CML pts in CCgR after IFN alpha.

Drug: Interpheron alpha

Interventions

Interpheron alpha DRUG

Long term outcom after interferon alpha discontinuation or not

CML and interpheron alpha

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Chair of hematology

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

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

Study Officials

• Domenico Russo

  Università degli Studi di Brescia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 13, 2011
• Study Start: October 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2014
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

IT (1)