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Clinical Guidelines for APL Treatment

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.
 
ClinicalTrials.gov Identifier: NCT02020161
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed

Condition or disease Intervention/treatment Phase
APL Drug: Atra Drug: Idarubicin Drug: methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ATRA-Idarubicin Drug: Atra
Drug: Idarubicin
Drug: methotrexate



Primary Outcome Measures :
  1. Recurrence within 1 year of treatment [ Time Frame: 3 years ]

    Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years).

    Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria:

  • No exclusion criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02020161


Contacts
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Contact: Pau Montesinos, Dr +34 96 1244000 montesinos_pau@gva.es
Contact: David Martinez, Dr +34 96 1244000. martinez_davcua@gva.es

Locations
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Spain
Hospital La Fe Recruiting
Valencia, Spain
Contact: Pau Montesinos, Dr       montesinos_pau@gva.es   
Sponsors and Collaborators
PETHEMA Foundation
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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT02020161    
Other Study ID Numbers: PETHEMA LPA2012
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Methotrexate
Idarubicin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors