Chronic Myeloid LeukemiaNCT01490853
Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy
An observational study of Chronic Myeloid Leukemia, run by Università degli Studi di Brescia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Interpheron alpha
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years old) patients with CP Ph+/BCR-ABL CML and with CCgR after therapy including IFN alpha.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission 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.
Read more
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.
Read the 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
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Interpheron alpha
- Keywords
- Ph pos CML, Philadelphia positive Chronic Myeloid Leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpheron alphaDrug
Long term outcom after interferon alpha discontinuation or not
| Study group | Role | What they receive |
|---|---|---|
| CML and interpheron alpha | Adult Ph+CML pts in CCgR after IFN alpha. Receives: Drug: Interpheron alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From date of enrollment until the date of first documented death from any cause, assessed up to 240 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenico Russo, Università degli Studi di Brescia
- Investigators
- Domenico Russo, Study director, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490853
- Sponsor's protocol ID
- CML0509
- Status last verified
- Nov 2018
- First submitted
- 1 Dec 2011
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy
- ClinicalTrials.gov ID
- NCT01490853
- Acronym / sponsor ID
- CML0509
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Ph pos CML, Philadelphia positive Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML and interpheron alpha | – | Drug: Interpheron alphaAdult Ph+CML pts in CCgR after IFN alpha. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years old) patients with CP Ph+/BCR-ABL CML and with CCgR after therapy including IFN alpha.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpheron alphaLong term outcom after interferon alpha discontinuation or not | Drug | CML and interpheron alpha |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Russo study director
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Università degli Studi di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From date of enrollment until the date of first documented progression, assessed up to 240 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.