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Trial record 3 of 144 for:    "Acute promyelocytic leukemia"

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

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ClinicalTrials.gov Identifier: NCT03096496
Recruitment Status : Unknown
Verified October 2017 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : March 30, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date January 24, 2017
First Posted Date March 30, 2017
Last Update Posted Date October 12, 2017
Actual Study Start Date March 27, 2017
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2017)
To examine long-term differences in health outcomes after treatment end. [ Time Frame: Two years after study entry. ]
Indicated by selected key-QoL outcomes, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.
Original Primary Outcome Measures
 (submitted: March 29, 2017)
Number of cross-sectional differences in fatigue severity [ Time Frame: Two years after study entry. ]
Change History Complete list of historical versions of study NCT03096496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2017)
  • 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. [ Time Frame: Two years after study entry. ]
    (including the functional status and symptomatology).
  • To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end. [ Time Frame: Two years after study entry. ]
    (as reported at 3rd consolidation).
  • To compare the long-term QoL profile, after treatment end, of APL patients treated with ATRA- chemotherapy and ATRA-ATO with that of their peers in the general population. [ Time Frame: Two years after study entry. ]
    Compared with the general population (without cancer).
  • To assess and compare the cumulative incidence and types of physician-reported late adverse effects (e.g. cardiac function) and secondary cancer, between randomized treatment groups. [ Time Frame: Two years after study entry. ]
    (ATRA plus chemotherapy versus ATRA plus ATO).
  • To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups. [ Time Frame: Two years after study entry. ]
    (ATRA plus chemotherapy versus ATRA plus ATO).
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2017)
To assess long-term QoL patterns over time of long-term APL survivors. [ Time Frame: Two years after study entry. ]
After treatment end, overall and by treatment group.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients previously enrolled in a phase III randomized controlled trial that compared the efficacy and toxicity of standard ATRA plus chemotherapy versus ATRA plus ATO in low-intermediate risk APL patients.
Condition Acute Promyelocytic Leukemia
Intervention Other: QoL questionnaires
Quality of life questionnaires
Study Groups/Cohorts GIMEMA APL0406 patients
APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment.
Intervention: Other: QoL questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 29, 2017)
276
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03096496
Other Study ID Numbers QoL-APL0816
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators Not Provided
Investigators
Study Chair: Fabio Efficace GIMEMA Foundation
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date October 2017