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
|Condition or disease||Intervention/treatment||Phase|
|APL||Drug: Atra Drug: Idarubicin Drug: methotrexate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
- 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.
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
|Contact: Pau Montesinos, Dr||+34 96 firstname.lastname@example.org|
|Contact: David Martinez, Dr||+34 96 email@example.com|
|Hospital La Fe||Recruiting|
|Contact: Pau Montesinos, Dr firstname.lastname@example.org|