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NCT00599937

Completed

APL93: Timing of CxT and Role of Maintenance

Leukemia, Promyelocytic, Acute

Drug: ATRA
Drug: ATRA and or Chemo as maintenance

Interventional

Phase 3

Groupe d'etude et de travail sur les leucemies aigues promyelocytaires
DRC lille, France

Other

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

For induction treatment event-free survival (EFS), calculated from the date of randomization, was the major endpoint.

576

All

Child, Adult, Senior

NCT00599937

APL93

January 1993

December 1998

January 24, 2008

NCT00465933

Completed

Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA)

Acute Promyelocytic Leukemia

Drug: AIDA

Interventional

Phase 4

PETHEMA Foundation

Other

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

To evaluate the efficacy of AIDA with a dose reduction in patients older than 70 years of age in the remission induction of APL
To evaluate the impact on morbidity and mortality of the prophylactic measures included in induction therapy (low dose prednisone and tranexamic acid)
To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy
(and 2 more...)

All

up to 75 Years (Child, Adult, Senior)

NCT00465933

Pethema LPA-99 protocol

March 1999

August 2007

November 2007

April 27, 2007

March 31, 2008

Basurtuko Ospitalea
Basurto, Spain
Hospital La Fe de Valencia
Valencia, Spain

NCT00408278

Completed

Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Acute Promyelocytic Leukemia

Drug: ATRA
Drug: Idarubicina
Drug: Mitoxantrone
Drug: ARA-C

Interventional

Phase 4

PETHEMA Foundation

Other

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival.
To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients on the event-free, disease-free, and overall survival
(and 2 more...)

300

All

up to 75 Years (Child, Adult, Senior)

NCT00408278

LPA 2005

July 2005

April 2012

December 2013

December 6, 2006

October 28, 2014

PALG
Lodz, Poland
Hospital General
Albacete, Spain
Hospital general
Alicante, Spain
(and 39 more...)

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