Status:
UNKNOWN
Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic
Lead Sponsor:
German AML Cooperative Group
Conditions:
Relapsed Acute Promyelocytic Leukemia
Refractory Acute Promyelocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby i...
Detailed Description
Synopsis Title of study Treatment of acute promyelocytic leukemia (APL) with arsenic trioxide (ATO). A phase-IV study to assess the effectiveness and toxicity of ATO as well as the kinetics of minim...
Eligibility Criteria
Inclusion
- Patients in first or subsequent hematological or molecular relapse of APL
- Persistence of a positive PCR or no hematological complete remission (CR) after first line therapy
- No complete hematological remission after first line therapy
- Age over 18 years
- No upper age limit
- Informed consent of the patient
Exclusion
- Absolute QTc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the QT-interval)
- Heart failure New York Health Association grade III and IV
- Renal or hepatic failure World Health Organization grade \>= III
- Pneumonia with hypoxemia
- Uncontrolled sepsis
- Pregnancy and lactation period
- Secondary malignancy, which will have major influence on the prognosis
- Expected noncompliance
- No informed consent of the patient.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00196768
Start Date
January 1 2005
End Date
December 1 2010
Last Update
October 23 2007
Active Locations (1)
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1
Eva Lengfelder, MD, PhD
Mannheim, Germany, 68305