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Acute Promyelocytic LeukemiaPhase 2NCT01064570

AIDA 2000 Guidelines

A Phase 2 study testing all-trans retinoic acid (ATRA) in people with Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse. Read more about this study

Who is it for?
Ages 1 year to 60 years
Conditions the study is for
Acute Promyelocytic Leukemia
What is being tested?
all-trans retinoic acid (ATRA)
How many people
600 participants
Where
3 sitesItaly
Study dates
May 2000to not given
Phase
Phase 2
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 1 year to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age >= 1 years and < 61 years
  • Morphologic diagnosis of APL
  • PS <= 3
  • Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement by RT-PCR. T
  • The presence of additional cytogenetic lesions is not considered an exclusion criterion
  • Serum creatinine <=2.5 mg/dL
Show all 9Show fewer
  • Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit
  • Negative pregnancy test
  • Written informed consent

Who cannot join

  • Age >= 61 years
  • Prior antileukemic chemotherapy for APL
  • Absence of PML-RARa rearrangement after successful RNA extraction and amplification of control gene
  • Prior antileikemic chemotherapy for APL
  • Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy
  • Oteher progressive malignant disease. However, secondary acute promyelocytic leukemia following "cured" Hodgkin's disease or otehr cured malignancies may be included, as well as secondary leukemias following other exposure to alkylating agents or radiation for other reasons

Trial locations and contacts

3 sites in 1 country.

Italy3 sites, 3 recruiting

  • Unità Operativa Ematologia 1 - Università degli Studi di Bari

    Bari, 70010

    Vincenzo LISO, v.liso@ematba.uniba.it

    Recruiting

  • Div. di Ematologia IRCCS Policlinico S. Matteo

    Pavia, 27100

    Mario LAZZARINO, mlazzarino@smatteo.pv.it

    Recruiting

  • A.O Umberto I

    Roma

    Franco MANDELLI, MD, PhD, gimema@gimema.it

    Recruiting

Other trials in Italy

About this study

Official title: Guidelines for Treatment of Acute Promyelocytic Leukemia

Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.

Being tested
all-trans retinoic acid (ATRA)
Keywords
Acute Promyelocytic Leukemia, APL
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.

  • all-trans retinoic acid (ATRA)Drug

What is being measured

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

  1. Treatment-related toxicity event rate during the ATRA-including consolidation treatment

    Measured: At the end of the study

Secondary outcomes (5)

  1. Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group

    Measured: At the end of the study

  2. The rates of molecular remission, after consolidation, in each risk group

    Measured: At the end of the study

  3. Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications

    Measured: At the end of the study

  4. The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group

    Measured: At the end of the study

  5. The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse

    Measured: At 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.

  1. First posted8 Feb 2010 (estimated)
  2. Study startMay 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064570
Sponsor's protocol ID
AIDA2000
Status last verified
Oct 2020
First submitted
5 Feb 2010
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Breccia M, Mazzarella L, Bagnardi V, Disalvatore D, Loglisci G, Cimino G, Testi AM, Avvisati G, Petti MC, Minotti C, Latagliata R, Foa R, Pelicci PG, Lo-Coco F. Increased BMI correlates with higher risk of disease relapse and differentiation syndrome in patients with acute promyelocytic leukemia treated with the AIDA protocols. Blood. 2012 Jan 5;119(1):49-54. doi: 10.1182/blood-2011-07-369595. Epub 2011 Nov 2.

    PubMed 22049518

  • Lo-Coco F, Avvisati G, Vignetti M, Breccia M, Gallo E, Rambaldi A, Paoloni F, Fioritoni G, Ferrara F, Specchia G, Cimino G, Diverio D, Borlenghi E, Martinelli G, Di Raimondo F, Di Bona E, Fazi P, Peta A, Bosi A, Carella AM, Fabbiano F, Pogliani EM, Petti MC, Amadori S, Mandelli F; Italian GIMEMA Cooperative Group. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group. Blood. 2010 Oct 28;116(17):3171-9. doi: 10.1182/blood-2010-03-276196. Epub 2010 Jul 19.

    PubMed 20644121

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing all-trans retinoic acid (ATRA) in people with Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 3 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related toxicity event rate during the ATRA-including consolidation treatment (time frame: At 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 NCT01064570, which also lists 2 linked publications.

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 14 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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