Chronic Myeloid LeukemiaNCT00896129
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites in Italy.
Trial summary
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib. 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?
- HRQOL Survey Packet
- How many people
- 448 participants
- Where
- 25 sitesItaly
- Study dates
- Mar 2010to Dec 2010
- 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 CML patiens under Imatinib treatment for at least three years
Who may be able to join
- Age 18 years.
- CML patients meeting the following criteria:
- Started IM therapy in the early chronic phase (ECP).
- Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM.
- In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC).
- Able to read and write Italian.
- Freedom from psychiatric conditions that may confound HRQOL evaluation.
- Informed consent provided.
Who cannot join
- CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
- Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
- Patients with a new primary malignancy.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
Nuovo ospedale "Torrette"
Ancona
Unità Operativa Ematologica - Università degli Studi di Bari
Bari, 70124
Ospedali Riuniti
Bergamo
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Bologna
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125
Azienda ASL di Cagliari
Cagliari, 9121
Ospedale Ferrarotto
Catania, 95124
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, 88100
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100
Clinica Ematologica - Università degli Studi
Genova
Ematologia 1 - Centro Trapianto di Midollo
Milan, 20122
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples, 80131
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
Naples, 80131
Ospedale S. Luigi Gonzaga
Orbassano, 10043
Ospedale Cervello
Palermo, 90146
Azienda ASL di Pescara
Pescara, 61100
Università di Pisa, Azienda Ospedaliera Pisana
Pisa, 72100
Ospedale S.Maria delle Croci
Ravenna, 48100
Ospedali Riuniti - Div. di Ematologia
Reggio Calabria, 85100
Università La Sapienza
Roma, 00100
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Sassari
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, 53100
Azienda USL 9 Treviso - U.O. di Ematologia
Treviso, 31100
Policlinico G.B. Rossi
Verona, 37134
About this study
Official title: Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.
Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
Read the detailed description
OBJECTIVES:
Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
Secondary evaluation of:
- Psychological wellbeing.
- Fatigue.
- Adherence to therapy issues.
- Symptom burden.
- Possible association between social-demographic and clinical variables with patient reported health outcomes.
OUTLINE:This is a multicenter study.
SAMPLE SIZE:
Sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center.
DURATION OF THE STUDY:
The recruitment period is estimated in approximately 6 to 12 months.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- HRQOL Survey Packet
- Keywords
- Health Outcomes Research, CML
- 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.
HRQOL Survey PacketOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Study population | Not described Receives: Other: HRQOL Survey Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
Measured: By the end of the study.
Secondary outcomes (5)
Psychological wellbeing.
Measured: By the end of the study.
Fatigue.
Measured: By the end of the study.
Adherence to therapy issues.
Measured: By the end of the study.
Symptom burden.
Measured: By the end of the study.
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Measured: By the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, PhD, Study chair, GIMEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896129
- Sponsor's protocol ID
- QOL-CML0208
- Status last verified
- Jan 2014
- First submitted
- 8 May 2009
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Barate C, Rossi AR, Fioritoni G, Luciano L, Turri D, Martino B, Di Raimondo F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Ulisciani S, Veneri D, Sica S, Rambaldi A, Vignetti M, Mandelli F; GIMEMA. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011 Oct 27;118(17):4554-60. doi: 10.1182/blood-2011-04-347575. Epub 2011 Jul 12.
PubMed 21750313
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.
- ClinicalTrials.gov ID
- NCT00896129
- Acronym / sponsor ID
- QOL-CML0208
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Health Outcomes Research, CML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 May 2009 (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.
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.
Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
Detailed description
OBJECTIVES:
Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
Secondary evaluation of:
- Psychological wellbeing.
- Fatigue.
- Adherence to therapy issues.
- Symptom burden.
- Possible association between social-demographic and clinical variables with patient reported health outcomes.
OUTLINE:This is a multicenter study.
SAMPLE SIZE:
Sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center.
DURATION OF THE STUDY:
The recruitment period is estimated in approximately 6 to 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: HRQOL Survey Packet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult CML patiens under Imatinib treatment for at least three years
Key inclusion criteria (8 listed)
- Age 18 years.
- CML patients meeting the following criteria:
- Able to read and write Italian.
- Freedom from psychiatric conditions that may confound HRQOL evaluation.
- Informed consent provided.
Key exclusion criteria (3 listed)
- CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
- Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
- Patients with a new primary malignancy.
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 |
|---|---|---|
| HRQOL Survey PacketQuestionnaires | Other | Study population |
Primary outcome
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
Time frame: By the end of the study.
5 secondary outcomes
Psychological wellbeing.
Time frame: By the end of the study.
Fatigue.
Time frame: By the end of the study.
Adherence to therapy issues.
Time frame: By the end of the study.
Symptom burden.
Time frame: By the end of the study.
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Time frame: By the end of the study.
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 22 Jan 2014.
- Background: PubMed 21750313Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Barate C, Rossi AR, Fioritoni G, Luciano L, Turri D, Martino B, Di Raimondo F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Ulisciani S, Veneri D, Sica S, Rambaldi A, Vignetti M, Mandelli F; GIMEMA. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011 Oct 27;118(17):4554-60. doi: 10.1182/blood-2011-04-347575. Epub 2011 Jul 12.
- Related InfoLink provided by the sponsor.
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Fabio Efficace, PhD study chair
GIMEMA Foundation
25 sites 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 Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites 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 8 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy. (time frame: By the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00896129, which also lists 1 linked publication.
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 22 Jan 2014.