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AIDA 2000 Guidelines

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier:
First received: February 5, 2010
Last updated: November 24, 2010
Last verified: November 2010
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 Intervention Phase
Acute Promyelocytic Leukemia Drug: all-trans retinoic acid (ATRA) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Guidelines for Treatment of Acute Promyelocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

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

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

Estimated Enrollment: 600
Study Start Date: May 2000

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Franco Mandelli, GIMEMA Identifier: NCT01064570     History of Changes
Other Study ID Numbers: AIDA2000
Study First Received: February 5, 2010
Last Updated: November 24, 2010

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 processed this record on September 19, 2017