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Acute Promyelocytic LeukemiaQOL-APL0512NCT01910623

Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia

An observational study of Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 38 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life. The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Promyelocytic Leukemia
What is being tested?
Health Related Quality of Life (HRQOL) measures
How many people
Not given
Where
38 sitesItaly
Study dates
Feb 2013to Jul 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: Acute promyelocytic patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000

Who may be able to join

  • APL patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000 surviving the initial diagnosis for more than 5 years and are in CR.
  • Written informed consent provided.
  • Adult patients at the time of registration onto this study.

Who cannot join

  • Concomitant major psychiatric disorders or cognitive dysfunctions that would interfere with a self-reported evaluation.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Italy38 sites

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"

    Ancona

  • Az.Ospedaliera S.G.Moscati

    Avellino

  • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

    Bari

  • Divisione di Ematologia - Ospedali Riuniti

    Bergamo

  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

    Bologna

  • Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO

    Bolzano

  • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia

    Brescia

  • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

    Cagliari

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • Policlinico di Careggi

    Florence

  • Clinica Ematologica - DiMI - Università degli Studi di Genova

    Genova

  • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

    Genova

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

  • Ospedale Niguarda " Ca Granda"

    Milan

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"

    Monza

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

  • Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo

    Naples

  • Sez. di Ematologia Clinica Ospedale San Francesco

    Nuoro

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

    Pavia

  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia

    Perugia

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Roma

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma

  • UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"

    Roma

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    S. G. Rotondo

  • SCDO Ematologia 2 AOU S.Giovanni Battista

    Torino

  • Clinica Ematologica - Policlinico Universitario

    Udine

  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

    Verona

  • ULSS N.6 Osp. S. Bortolo

    Vicenza

Other trials in Italy

About this study

Official title: Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia: a Follow-up Observational Study of Patients Enrolled in the GIMEMA AIDA 0493 and AIDA 200

This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life.

The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these in patients' life.

Read the detailed description

This study will focus on long-term survivors as defined by the America Cancer Society, that is surviving the initial diagnosis for more than 5 years. Previous research has investigated long-term Health Related Quality of Life (HRQOL) in patients with acute myeloid leukemia, however, this will be the first research conducted to investigate long-term HRQOL outcomes in patients with acute promyelocytic leukemia (APL).

The potential late effects of cancer treatment can include second malignancies or other chronic conditions affecting physical and emotional well-being. Therefore, there has been an increasing interest worldwide in evaluating the longer-term impact of cancer and its treatment. Currently large cohort of patients enjoys disease-free survival of 5 years or longer. However, a disease-free status is not synonymous with a life free of physical and psychological health related to the cancer and/or its treatment. Research shows that cancer related health concerns persist long after initial treatment and this has been shown in several cancer populations including prostate, testicular, breast cancer and lymphoma patients. Long-term cancer survivors can experience treatment-induced morbidity (e.g. cardiovascular damage due to chemotherapy or radiotherapy; infertility and second tumors), chronic disease and treatment-related symptoms, functional impairment, psychosocial problems, and practical problems.

Since the introduction of the vitamin A derivative all-trans retinoic acid (ATRA) as front-line therapy for APL, the outcome of this acute leukemia subtype has changed from the state of a most frequently fatal leukemia to the condition of a highly curable disease. The Italian cooperative group GIMEMA designed in 1993 the AIDA (Atra plus IDArubicin) trial for newly diagnosed APL. Results on over 800 patients showed a complete remission (CR) rate > 90% and an overall survival of 76% and confirmed that the concomitant administration of ATRA and chemotherapy is more effective than the sequential administration. Following the identification of distinct prognostic categories among APL patients, the GIMEMA group designed a new trial (AIDA2000) in which the intensity of post-remission treatment was adapted to the relapse risk and 498 patients were enrolled since January 2000. The results recently published showed a CR rate >90% with molecular remission rate after third consolidation of 98%. The new schedule allowed a Disease Free Survival (DFS) of 86% and showed that a risk-adapted strategy including ATRA for consolidation provides an outcome improvement in newly diagnosed patients. As reported by an international panel of experts, simultaneous ATRA and anthracycline chemotherapy schedules such as those used in the AIDA protocols represent the state of the art therapy for newly diagnosed APL.

Being tested
Health Related Quality of Life (HRQOL) measures
Keywords
Quality of life, Health related quality of life outcomes, Long-term, Aida 0493, AIDA 2000
Medical subject headings
Leukemia, Promyelocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Related Quality of Life (HRQOL) measuresOther

    Also called SF-36 health survey., EORTC QOL-C30 questionnaire., FACIT-Fatigue questionnaire., Self-administered Comorbidity Questionnaire (SCQ).

Study groups in NCT01910623
Study groupRoleWhat they receive
Patients being studiedAPL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.
Receives: Other: Health Related Quality of Life (HRQOL) measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical significance on each of the SF-36 questionnaire scales.

    This will be performed by using HRQOL scores available for the Italian population. This will help identify which specific areas are mostly impaired and to what extent these patients recover in terms of HRQOL over the long run. This kind of comparison, which is only possible when HRQOL cultural-based norms are available, is largely used when investigating long-term HRQOL in cancer survivors and it is widely recognized as one of the most valuable approach in this kind of research setting.

    Measured: One month from study entry.

Secondary outcomes (5)

  1. Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.

    Measured: One month from study entry.

  2. Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials.

    Measured: One month from study entry.

  3. Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials.

    Measured: One month from study entry.

  4. Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials.

    Measured: One month from study entry

  5. Possible differences in EORTC-QLQC30, MDASI and SF-36 scales between patients who were less than eighteen years old at the time of diagnosis and patients who were at least eighteen years old at the time of diagnosis.

    Measured: One month from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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-control
Time perspective
Cross-sectional
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910623
Sponsor's protocol ID
QOL-APL0512
Acronym
QOL-APL0512
Status last verified
Oct 2014
First submitted
28 Mar 2013
Last updated
2 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 38 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 3 inclusion and 1 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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?

Clinical significance on each of the SF-36 questionnaire scales. (time frame: One month from study entry.). 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 NCT01910623.

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 2 Oct 2014.

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