AIDA 2000 Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01064570
Recruitment Status : Recruiting
First Posted : February 8, 2010
Last Update Posted : February 21, 2018
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: all-trans retinoic acid (ATRA) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Guidelines for Treatment of Acute Promyelocytic Leukemia
Study Start Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Tretinoin
U.S. FDA Resources

Primary Outcome Measures :
  1. Treatment-related toxicity event rate during the ATRA-including consolidation treatment [ Time Frame: At the end of the study ]

Secondary Outcome Measures :
  1. Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group [ Time Frame: At the end of the study ]
  2. The rates of molecular remission, after consolidation, in each risk group [ Time Frame: 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 [ Time Frame: At the end of the study ]
  4. The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group [ Time Frame: 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 [ Time Frame: At the end of the study ]

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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit
  • Negative pregnancy test
  • Written informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01064570

Unità Operativa Ematologia 1 - Università degli Studi di Bari Recruiting
Bari, Italy, 70010
Contact: Vincenzo LISO   
Div. di Ematologia IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy, 27100
Contact: Mario LAZZARINO   
A.O Umberto I Recruiting
Roma, Italy
Contact: Franco MANDELLI, MD, PhD   
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications of Results:
Other Publications:
Responsible Party: Prof. Franco Mandelli, GIMEMA Identifier: NCT01064570     History of Changes
Other Study ID Numbers: AIDA2000
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute Promyelocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents