Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy

Chronic Myeloid Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896129
• Other study ID #: QOL-CML0208
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: January 21, 2014
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2014
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• HRQOL Survey Packet
Questionnaires

Locations

Country	Name	City	State
Italy	Nuovo ospedale "Torrette"	Ancona
Italy	Unità Operativa Ematologica - Università degli Studi di Bari	Bari
Italy	Ospedali Riuniti	Bergamo
Italy	Ist.Ematologia e Oncologia Medica L.e A. Seragnoli	Bologna
Italy	Sezione di Ematologia e Trapianti Spedali Civili	Brescia
Italy	Azienda ASL di Cagliari	Cagliari
Italy	Ospedale Ferrarotto	Catania
Italy	Azienda Ospedaliera Pugliese Ciaccio	Catanzaro
Italy	Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna	Ferrara
Italy	Clinica Ematologica - Università degli Studi	Genova
Italy	Ematologia 1 - Centro Trapianto di Midollo	Milano
Italy	Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"	Napoli
Italy	Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"	Napoli
Italy	Ospedale S. Luigi Gonzaga	Orbassano
Italy	Ospedale Cervello	Palermo
Italy	Azienda ASL di Pescara	Pescara
Italy	Università di Pisa, Azienda Ospedaliera Pisana	Pisa
Italy	Ospedale S.Maria delle Croci	Ravenna
Italy	Ospedali Riuniti - Div. di Ematologia	Reggio Calabria
Italy	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma
Italy	Università La Sapienza	Roma
Italy	Serv. di Ematologia Ist. di Ematologia ed Endocrinologia	Sassari
Italy	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena
Italy	Azienda USL 9 Treviso - U.O. di Ematologia	Treviso
Italy	Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Baratè 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		By the end of the study.
Secondary	Psychological wellbeing.		By the end of the study.
Secondary	Fatigue.		By the end of the study.
Secondary	Adherence to therapy issues.		By the end of the study.
Secondary	Symptom burden.		By the end of the study.
Secondary	Possible association between socio-demographic and clinical variables with patient reported health outcomes.		By the end of the study.

External Links

•   Link