Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

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Brief Title

Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

Official Title

Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy

Brief Summary

      This is a prospective and international observational study run by the GIMEMA. All data will
      be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients
      reported outcomes will be collected using internationally validated questionnaires.
    



Study Type

Observational


Primary Outcome

To examine long-term differences in health outcomes after treatment end.

Secondary Outcome

 To examine long-term differences in health outcomes after treatment end indicated by all QoL outcomes not considered in primary objectives, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.

Condition

Acute Promyelocytic Leukemia

Intervention

QoL questionnaires

Study Arms / Comparison Groups

 GIMEMA APL0406 patients
Description:  APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

276

Start Date

March 27, 2017

Completion Date

February 2019

Primary Completion Date

February 2019

Eligibility Criteria

        Inclusion Criteria:

          -  APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR
             after third consolidation treatment

          -  Written informed consent.

        Exclusion Criteria:

          -  APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who
             are lost to follow-up.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Fabio Efficace, +39 06.70390521, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT03096496

Organization ID

QoL-APL0816


Responsible Party

Sponsor

Study Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto


Study Sponsor

Fabio Efficace, Study Chair, GIMEMA Foundation


Verification Date

October 2017