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Trial record 12 of 115 for:    "Acute promyelocytic leukemia"
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AIDA 2000 Guidelines

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01064570
First received: February 5, 2010
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Guidelines for Treatment of Acute Promyelocytic Leukemia

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • The rates of molecular remission, after consolidation, in each risk group [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2000
  Eligibility

Ages Eligible for Study:   1 Year to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064570

Locations
Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari Recruiting
Bari, Italy, 70010
Contact: Vincenzo LISO         v.liso@ematba.uniba.it    
Div. di Ematologia IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy, 27100
Contact: Mario LAZZARINO         mlazzarino@smatteo.pv.it    
A.O Umberto I Recruiting
Roma, Italy
Contact: Franco MANDELLI, MD, PhD         gimema@gimema.it    
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
  More Information

No publications provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Franco Mandelli, GIMEMA
ClinicalTrials.gov Identifier: NCT01064570     History of Changes
Other Study ID Numbers: AIDA2000
Study First Received: February 5, 2010
Last Updated: November 24, 2010
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
 Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013